Mga Batayang Estadistika
| LEI | 7245009C5FZE6G9ODQ71 |
| CIK | 1697862 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to argenx SE
SEC Filings (Chronological Order)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| August 25, 2025 |
Exhibit 99.1 argenx Announces Positive Topline Results from ADAPT SERON Study of VYVGART in Patients with AChR-Ab Seronegative gMG - Study met primary endpoint (p-value=0.0068) - First global phase 3 study to demonstrate clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, triple seronegative - Supplemental Biologics License Application (sBLA) to be subm |
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| August 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of August 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive off |
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| July 31, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands. (Address of principal executive offi |
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| July 31, 2025 |
argenx Reports Half Year 2025 Financial Results and Provides Second Quarter Business Update $949 million in second quarter global product net sales VYVGART SC launch in CIDP progresses with more than 2,500 patients on treatment globally ARGX-119 to advance to registrational study in CMS following positive proof of concept data; three additional topline data readouts across pipeline remain on track |
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| July 31, 2025 |
argenx2q2025investorpres Reaching Patients Through Immunology Innovation 2 Q 2 0 2 5 F I N A N C I A L R E S U L T S C A L L J U L Y 3 1 , 2 0 2 5 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. |
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| July 31, 2025 |
argenx Half-Year 2025 Financial Report 2025 Half-Year Financial Report argenx Half-Year 2025 Financial Report 1 Table of Contents Management report 2 1Main events in the first six months of 2025 2 2Financial highlights 4 3Risk factors 5 4Forward-looking statements 5 5Statement of the board of directors 6 Unaudited condensed consolidated interim financial statements 7 Unaudited condensed consolidated interim statements of financial posi |
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| June 30, 2025 |
Exhibit 99.1 argenx Advances Clinical Development of ARGX-119 in Congenital Myasthenic Syndromes Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP |
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| June 30, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 20, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 20, 2025 |
Exhibit 99.1 argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy · VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP · Approval based on ADHERE clinical trial, the largest study of CIDP patients to date · First nove |
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| June 11, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 11, 2025 |
Exhibit 99.1 argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren’s Disease · ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod · RHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcome |
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| May 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive office |
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| May 28, 2025 |
argenx Announces Results of Annual General Meeting of Shareholders Exhibit 99.1 argenx Announces Results of Annual General Meeting of Shareholders May 28, 2025 – 10:01 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the results of its Annual General Meeting of shareholders held on May 27, 2025. 91.1% of the Company’s |
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| May 8, 2025 |
Reaching Patients Through Immunology Innovation 1 Q 2 0 2 5 F I N A N C I A L R E S U L T S C A L L M A Y 8 , 2 0 2 5 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. |
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| May 8, 2025 |
argenx Reports First Quarter 2025 Financial Results and Provides Business Update $790 million in first quarter global product net sales First patients treated with VYVGART Hytrulo pre-filled syringe for self-injection in US and Germany CIDP global expansion with positive CHMP opinion for VYVGART-SC (vial and pre-filled syringe) in EU Management to host conference call today at 2:30 PM CET (8:30 AM ET) May 8, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its first quarter 2025 financial results and provided a business update. |
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| May 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive office |
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| April 28, 2025 |
EX-99.1 2 tm2513185d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) · VYVGART® is first-and-only targeted IgG Fc-antibody fragment for CIDP · First novel mechanism of action for CIDP treatment in more than 30 years · CHMP positive opinion based on ADHERE |
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| April 28, 2025 |
6-K 1 tm2513185d16k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Ad |
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| April 14, 2025 |
argenx Announces Annual General Meeting of Shareholders on May 27, 2025 Exhibit 99.1 argenx Announces Annual General Meeting of Shareholders on May 27, 2025 April 11, 2025, 10:01 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Annual General Meeting of shareholders will be held at 13:00 CET on Tuesday, May |
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| April 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| April 11, 2025 |
Exhibit 99.1 argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy · VYVGART, the first-in-class FcRn blocker, now offers three administration options, including self-injection with a prefilled syringe · Self-injection provides gMG and CIDP patients with flexibility for when and w |
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| April 11, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| April 8, 2025 |
Exhibit 99.1 argenx Highlights VYVGART Data at AAN 2025 Setting New Standard in Sustained Efficacy and Improved Quality of Life Measures for Patients Living with gMG and CIDP · ADAPT-NXT data demonstrate consistent, sustained disease control across dosing schedules, further supporting individualized VYVGART dosing for gMG patients · ADHERE+ oral presentation features long-term CIDP data demonstrat |
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| April 8, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 20, 2025 |
EQUITY INCENTIVE PLAN 2024 as approved by the board of directors of argenx SE on 27 February 2024 Exhibit 4.3 EQUITY INCENTIVE PLAN 2024 as approved by the board of directors of argenx SE on 27 February 2024 1.INTRODUCTION 1.1.Purpose Our mission is to transform patients’ lives by providing them with life-changing medicines which build on scientific breakthroughs in immunology. Our future success is largely dependent on our ability to attract and retain highly qualified individuals such as you |
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| March 20, 2025 |
Part AExecutive Director and Non-Executive Director Exhibit 11.1 Insider Trading Policy Page 1 of 21 1.PURPOSE The Insider Trading Policy is intended to raise and maintain Insiders’ awareness about the prohibition of trading in the Company’s Financial Instruments while having Inside Information and about the other related prohibitions under the DFSA, the BFSA, the Market Abuse Regulation and the US federal securities laws and to ensure that any Ins |
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| March 20, 2025 |
Exhibit 15.2 Deloitte Accountants B.V. Audit & Assurance None Wilhelminakade 1 3072 AP Rotterdam P.O. Box 2031 3000 CA Rotterdam The Netherlands Tel: +31 (0)88 288 2888 www.deloitte.nl March 20, 2025 Securities and Exchange Commission 100 F Street, N.E. WASHINGTON, D.C. 20549-7561 Dear Sirs/Madams, We have read Item 16F of argenx SE's Form 20-F dated March 20, 2025, and we agree with the statement |
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| March 20, 2025 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE |
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| March 20, 2025 |
Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 20-F of argenx SE (the "Company") for the fiscal year ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursu |
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| March 20, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 20, 2025 |
Consent of independent registered public accounting firm Exhibit 15.1 Consent of independent registered public accounting firm We consent to the incorporation by reference in Registration Statements Nos. 333-225375, 333-258253 and 333-274721 on Form S-8 of our reports dated March 20, 2025, relating to the financial statements of argenx SE and the effectiveness of argenx SE’s internal control over financial reporting appearing in this Annual Report on Fo |
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| March 20, 2025 |
Exhibit 1.2 RULES (BY-LAWS) FOR THE BOARD OF DIRECTORS OF ARGENX SE as approved by the board of directors of argenx SE on 12 December 2023 1.Status of these Rules These rules (the "Rules") of the board of directors (the “Board”) of argenx SE (the “Company”) have been established by the Board on 12 December 2023 replacing any previously applicable Board Rules. 2.Board Composition and Committees 2.1 |
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| March 20, 2025 |
Exhibit 12.1 CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Tim Van Hauwermeiren, certify that: 1.I have reviewed this Annual Report on Form 20-F of argenx SE; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a mat |
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| March 20, 2025 |
Exhibit 12.2 CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Karl Gubitz, certify that: 1.I have reviewed this Annual Report on Form 20-F of argenx SE; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fac |
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| March 20, 2025 |
Exhibit 2.3 DESCRIPTION OF SHARE CAPITAL argenx SE (Company, argenx, we, us, and our) has one class of securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (Exchange Act): ordinary shares, including ordinary shares represented by American Depositary Shares (ADSs, each an ADS). The following description is a summary of certain information relating to ou |
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| March 20, 2025 |
Annual Report 2024 2024 Annual Report including the Annual Financial Statements for the year ended December 31, 2024 This Annual Report is filed with the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiële Markten, AFM). |
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| March 20, 2025 |
Unofficial translation of the articles of association of Exhibit 1.1 Unofficial translation of the articles of association of argenx SE as they read after the execution of a deed of partial amendment of the articles of association before Dirk-Jan Jeroen Smit, civil law notary in Amsterdam, the Netherlands, on 7 May 2024. Please note that this is an unofficial office translation, in which an attempt has been made to be as literal as possible without jeop |
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| March 20, 2025 |
Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 1.In connection with the Annual Report on Form 20-F of argenx SE (the "Company") for the fiscal year ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I certify, pursuant to 18 U.S.C. § 1350, as adopted pur |
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| March 7, 2025 |
Exhibit 99.1 argenx Highlights FcRn Leadership with Long-term Data and Transformational Patient Outcomes at the American Academy of Neurology 2025 Annual Meeting · Largest safety data set on FcRn blocking demonstrates consistent, favorable safety profile of VYVGART and VYVGART Hytrulo · gMG patients on VYVGART achieve rapid, substantial, and sustained efficacy across multiple dosing regimens, supp |
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| March 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| February 27, 2025 |
Reaching Patients Through Immunology Innovation 4 Q 2 0 2 4 F I N A N C I A L R E S U L T S C A L L F E B R U A R Y 2 7 , 2 0 2 5 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. |
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| February 27, 2025 |
argenx Reports Full Year 2024 Financial Results and Provides Fourth Quarter Business Update $737 million in fourth quarter and $2. |
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| February 27, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of February 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| February 27, 2025 |
ARGENX SE UNAUDITED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION As of December 31, (in thousands of $) 2024 2023 2022 Assets Non‑current assets Property, plant and equipment $ 43,517 $ 22,675 $ 16,234 Intangible assets 181,445 125,228 174,901 Deferred tax assets 924,299 97,211 79,222 Research and development incentive receivables 94,854 76,706 47,488 Investment in a joint venture 9,268 9,912 1,3 |
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| January 13, 2025 |
Exhibit 99.1 argenx Highlights 2025 Strategic Priorities Reported $2.2 billion in preliminary* full-year 2024 global product net sales, inclusive of $737 million in fourth quarter sales Pre-filled syringe FDA PDUFA on track for April 2025 to support reaching patients earlier in treatment paradigm 10 ongoing registrational studies in 2025 across efgartigimod and empasiprubart enable next wave of in |
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| January 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2025 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive of |
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| January 13, 2025 |
Exhibit 99.2 The Next Wave of Innovation 43rd ANNUAL JP MORGAN HEALTHCARE CONFERENCE JANUARY 13, 2025 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter |
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| December 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of December 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| December 27, 2024 |
Exhibit 99.1 argenx Announces Approval of VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) in Japan for Adults with Chronic Inflammatory Demyelinating Polyneuropathy VYVDURA® now approved for at-home self-injection in Japan for both generalized myasthenia gravis and CIDP argenx's VYVGART® and VYVDURA portfolio approved in Japan for three indications – first country globally with access across th |
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| November 20, 2024 |
Exhibit 99.1 argenx Advances Clinical Development of Efgartigimod SC in Idiopathic Inflammatory Myopathies - Phase 2 data establish proof-of-concept of efgartigimod SC in myositis - Enrollment to continue in Phase 3 across all three subtypes (IMNM, ASyS, DM) under evaluation in ALKIVIA - Potential for efgartigimod SC to be first targeted approach for myositis patients who have limited treatment op |
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| November 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of November 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| November 12, 2024 |
Exhibit 99.1 argenx and Zai Lab Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in China First and only NMPA-approved treatment for patients with CIDP in China Second VYVGART Hytrulo indication approved in China November 11, 2024 – 7:30am ET Amsterdam, the Netherlands— argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) toda |
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| November 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of November 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| October 31, 2024 |
Reaching Patients Through Immunology Innovation 3 Q 2 0 2 4 E A R N I N G S C A L L | O c t o b e r 3 1 , 2 0 2 4 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. |
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| October 31, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of October 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogteweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| October 31, 2024 |
argenx Reports Third Quarter 2024 Financial Results and Provides Business Update $573 million in third quarter global net product sales CIDP global expansion on track, with decisions on approval under review in Japan, Europe, China, and Canada Management to host conference call today at 1:30 PM CET (8:30 AM ET) Regulated information - Inside information October 31, 2024 7:00AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its third quarter 2024 financial results and provided a business update. |
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| October 15, 2024 |
Exhibit 99.1 argenx Highlights Data Showing Patient Impact Across Multiple Immunology Programs at 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and Myasthenia Gravis Foundation of America Scientific Sessions Long-term and real-world data of VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) demonstrate speed of |
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| October 15, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of October 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive of |
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| September 19, 2024 |
Exhibit 99.1 argenx Announces Publication in The Lancet Neurology of Pivotal ADHERE Study Data in Chronic Inflammatory Demyelinating Polyneuropathy ADHERE was largest and most innovative clinical trial of CIDP patients to date VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) demonstrated reduction in disease progression, reduced risk of relapse and rapid onset of action VYVGART Hytrulo |
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| September 19, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of September 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive |
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| July 25, 2024 |
Table of Contents TABLE OF CONTENTS MANAGEMENT REPORT 1. MAIN EVENTS IN THE SIX MONTHS OF 2024 2 2. FINANCIAL HIGHLIGHTS 3 3. RISK FACTORS 4 4. FORWARD-LOOKING STATEMENTS 4 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION 6 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS 8 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LO |
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| July 25, 2024 |
Ex* reflects cash, cash equivalents and current financial assets hibit 99.1 argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update $478 million in second quarter global net product sales First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval On track to begin four additional registrational studies across efgartigimod and empasiprubar |
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| July 25, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| July 16, 2024 |
Exhibit 99.1 |
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| July 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| July 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| July 16, 2024 |
Exhibit 99.1 argenx and Zai Lab Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China First and only NMPA-approved subcutaneous injectable FcRn blocker for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study July 16, 2024 6:30am CET Amsterdam, the |
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| June 25, 2024 |
Exhibit 99.1 argenx Highlights Breadth of Autoimmune Pipeline with New Multifocal Motor Neuropathy Data at 2024 Peripheral Nerve Society Annual Meeting ARDA study data show potential for empasiprubart to drive functional improvement and reduced risk of relapse for multifocal motor neuropathy (MMN) patients ADHERE+ data show durability of functional improvements with VYVGART® Hytrulo (efgartigimod |
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| June 25, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 24, 2024 |
Exhibit 99.2 VYVGART® HYTRULO NOW INDICATED FOR CIDP FDA APPROVAL CALL | JUNE 21, 2024 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company |
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| June 24, 2024 |
Exhibit 99.1 argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) First novel, precision mechanism of action in more than 30 years for patients with CIDP Third approved indication for VYVGART® and VYVGART |
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| June 17, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 17, 2024 |
Exhibit 99.1 argenx to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients’ during its Upcoming R&D Day on July 16, 2024 R&D Day presentations to include recent Phase 2 datasets in Sjogren’s disease (efgartigimod) and multifocal motor neuropathy (empasiprubart) that support advancement to Phase 3 development Next wave of innovative pipeline candidates to be introduced highlight |
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| May 9, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive office |
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| May 9, 2024 |
Exhibit 99.1 argenx Reports First Quarter 2024 Financial Results and Provides Business Update $398 million in first quarter global net product sales FDA review ongoing for CIDP sBLA with PDUFA target action date of June 21, 2024 On track to submit filing for pre-filled syringe (PFS) in second quarter 2024 Management to host conference call today at 2:30 PM CET (8:30 AM ET) May 9, 2024, 7:00 AM CET |
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| May 8, 2024 |
argenx announces results of Annual General Meeting of Shareholders Exhibit 99.1 argenx announces results of Annual General Meeting of Shareholders May 7, 2024 – 5:30pm ET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the results of its Annual General Meeting of shareholders held today. All items on the agenda received a m |
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| May 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive office |
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| April 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| April 16, 2024 |
Exhibit 99.1 argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease ADHERE data show VYVGART® Hytrulo has potential to be first advancement for CIDP patients in 30 years Real-world data demonstrate gMG patients able to significantly reduce steroid use over first six months of initiating VYVGART® treatment Apri |
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| March 27, 2024 |
ANNUAL GENERAL MEETING 7 MAY 2024 OF ARGENX SE EXPLANATORY NOTES Exhibit 99.4 ANNUAL GENERAL MEETING 7 MAY 2024 OF ARGENX SE EXPLANATORY NOTES The following items on the agenda of the meeting of argenx SE (the "Company") shall be discussed and/or put to a vote. The numbers in the list correspond to the numbers on the agenda. 2. Report on the 2023 financial year (discussion item) This agenda item includes an account of the financial year 2023. 3. The 2023 remune |
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| March 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 27, 2024 |
argenx Announces Annual General Meeting of Shareholders on May 7, 2024 Exhibit 99.1 argenx Announces Annual General Meeting of Shareholders on May 7, 2024 March 26, 2024 Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Annual General Meeting of shareholders will be held at 13:00 CET on Tuesday, May 7, 2024 at the |
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| March 27, 2024 |
CONVOCATION ANNUAL GENERAL MEETING OF ARGENX SE 7 MAY 2024 Exhibit 99.2 CONVOCATION ANNUAL GENERAL MEETING OF ARGENX SE 7 MAY 2024 argenx SE (the "Company") hereby invites its shareholders and all other persons with meeting rights to attend its annual general meeting of shareholders ("AGM") to be held at 13:00 CET on Tuesday, May 7, 2024 at Hilton Hotel Schiphol, Schiphol Boulevard 701, 1118 BN Schiphol, the Netherlands. We would like to emphasize and enc |
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| March 27, 2024 |
PROXY FORM ANNUAL GENERAL MEETING ARGENX SE MAY 7, 2024 Exhibit 99.5 PROXY FORM ANNUAL GENERAL MEETING ARGENX SE MAY 7, 2024 IMPORTANT NOTICE: for the annual general meeting 2024 argenx uses the e-voting system of ABN AMRO. The company therefore kindly requests all shareholders who wish to vote at the general meeting but cannot/do not wish to attend, to use the proxy/e-voting services of ABN via HTTPS://WWW.ABNAMRO.SECURITIESVOTING.COM/SHAREHOLDER/ The |
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| March 27, 2024 |
ANNUAL GENERAL MEETING OF ARGENX SE OF 7 MAY 2024 Exhibit 99.3 ANNUAL GENERAL MEETING OF ARGENX SE OF 7 MAY 2024 AGENDA 1. Opening 2. Report on the 2023 financial year (discussion item) 3. The 2023 remuneration report (advisory non-binding voting item) 4. Discussion and adoption of the 2023 annual report and annual accounts: a. Discussion of the 2023 annual report (discussion item) b. Adoption of the 2023 annual accounts (voting item) c. Corporat |
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| March 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 27, 2024 |
Exhibit 99.1 argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease RHO study supports proof-of-concept in primary Sjogren’s disease Decision informed by favorable safety profile and consistency across efficacy and biomarker measures March 27, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to impr |
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| March 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 26, 2024 |
Exhibit 99.1 argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia VYVGART® now approved in Japan for both generalized myasthenia gravis and primary immune thrombocytopenia (ITP) Regulatory decision in Japan represents first global approval for VYVGART in ITP March 26, 2024 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Na |
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| March 21, 2024 |
Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 20-F of argenx SE (the "Company") for the fiscal year ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursu |
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| March 21, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF |
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| March 21, 2024 |
Exhibit 12.1 CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Tim Van Hauwermeiren, certify that: 1.I have reviewed this Annual Report on Form 20-F of argenx SE; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a mat |
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| March 21, 2024 |
EQUITY INCENTIVE PLAN 2023 as approved by the board of directors of argenx SE on 2 May 2023 Exhibit 4.4 EQUITY INCENTIVE PLAN 2023 as approved by the board of directors of argenx SE on 2 May 2023 1.INTRODUCTION 2.GRANTING EQUITY INCENTIVES 1.1.PURPOSE 2.1.ELIGIBILITY TO PARTICIPATE IN THIS PLAN Our mission is to transform patients’ lives by providing them with life-changing medicines which build on scientific breakthroughs in immunology. Our future success is largely dependent on our abi |
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| March 21, 2024 |
Consent of independent registered public accounting firm Exhibit 15.1 Consent of independent registered public accounting firm We consent to the incorporation by reference in Registration Statements Nos. 333-225375, 333-258253 and 333-274721 on Form S-8 and Registration Statement No. 333-258251 on Form F-3 of our reports dated March 21, 2024, relating to the financial statements of argenx SE and the effectiveness of argenx SE’s internal control over fin |
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| March 21, 2024 |
Exhibit 2.3 DESCRIPTION OF SHARE CAPITAL argenx SE (Company, argenx, we, us, and our) has one class of securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (Exchange Act): ordinary shares, including ordinary shares represented by American Depositary Shares (ADSs). The following description is a summary of certain information relating to our share capit |
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| March 21, 2024 |
Exhibit 12.2 CERTIFICATION PURSUANT TO RULES 13A-14(A) AND 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Karl Gubitz, certify that: 1.I have reviewed this Annual Report on Form 20-F of argenx SE; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fac |
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| March 21, 2024 |
Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 20-F of argenx SE (the "Company") for the fiscal year ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursu |
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| March 21, 2024 |
Exhibit 99.1 AnnualReport2023 Disclaimer PDF print – this document is only a “printed version” and is not the original annual financial reporting including the audited financial statements pursuant to Article 361 of Book 2 of the Dutch Civil Code. These original annual financial reporting included in the audited financial statements and the auditor’s report thereto, are included in the single repo |
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| March 21, 2024 |
argenx SE EXECUTIVE COMPENSATION CLAWBACK POLICY Exhibit 97.1 argenx SE EXECUTIVE COMPENSATION CLAWBACK POLICY 1.Purpose. The purpose of this Policy is to set forth the circumstances under which Executive Officers of the Company will be required to repay or return certain Excess Awarded Compensation to members of the Company Group. The Board has adopted this Policy in accordance with the Clawback Rule and the Listing Rule and it is intended to c |
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| March 21, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 8, 2024 |
Exhibit 99.1 argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting ADHERE data presentation will highlight first potential innovation for CIDP patients in 30 years Abstracts reflect real-world value and consistent efficacy and safety profile associated with long-term use of VYVGART® and VYVGART® Hytrulo in gMG patients Mar |
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| March 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| February 29, 2024 |
Exhibit 99.1 argenx Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update $374 million in fourth quarter and $1.2 billion in full year global net product sales sBLA for VYVGART® Hytrulo for CIDP accepted for priority review by FDA with PDUFA target action date of June 21, 2024 On track to report data from six Phase 2 proof-of-concept trials by end of 2024 Management |
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| February 29, 2024 |
ARGENX SE CONSOLIDATED STATEMENTS OF FINANCIAL POSITION Exhibit 99.3 ARGENX SE CONSOLIDATED STATEMENTS OF FINANCIAL POSITION As of December 31, (in thousands of $) 2023 2022 2021 ASSETS Non-current assets Property, plant and equipment $ 22,675 $ 16,234 $ 15,844 Intangible assets 125,228 174,901 171,684 Deferred tax asset 97,211 79,222 32,191 Research and development incentive receivables 76,706 47,488 32,707 Investment in joint venture 9,912 1,323 — Pr |
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| February 29, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of February 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| February 29, 2024 |
Exhibit 99.2 Reaching Patients through Immunology Innovation F Y / 4 Q 2 0 2 3 E A R N I N G S C A L L | F E B R U A R Y 2 9 , 2 0 2 4 Forward Looking Statements • This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise |
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| February 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of February 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| February 20, 2024 |
Exhibit 99.1 argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024 If approved, VYVGART® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP February 20, 2024, 7:00 AM CET Amsterdam, |
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| February 12, 2024 |
EX-99.1 2 d758086dex991.htm EX-99.1 EXHIBIT 1 JOINT FILING AGREEMENT The undersigned hereby agree to the joint filing of the Schedule 13G to which this Agreement is attached. Dated: 2/12/2024 ARTISAN PARTNERS ASSET MANAGEMENT INC, for itself and as the general partner of ARTISAN PARTNERS HOLDINGS LP By: Gregory K. Ramirez * ARTISAN INVESTMENTS GP LLC, for itself and as the general partner of ARTIS |
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| February 12, 2024 |
SC 13G 1 d758086dsc13g.htm SC 13G SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G (Rule 13d-102) Information to be Included in Statements Filed Pursuant to Rule 13d-1(b), (c) and (d) and Amendments Thereto Filed Pursuant to Rule 13d-2. Under the Securities Exchange Act of 1934 (Amendment No. )* Argenx SE (Name of Issuer) American Depositary Shares (Title of Class of Securit |
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| January 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive of |
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| January 18, 2024 |
Exhibit 99.1 argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis • Availability of VYVGART® and self-administered VYVDURA demonstrates continued commitment to providing more choice and flexibility for gMG patients in Japan Jan. 18, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronex |
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| January 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2024 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive of |
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| January 8, 2024 |
Exhibit 99.1 argenx Highlights 2024 Strategic Priorities Reported $1.2 billion in preliminary* full-year 2023 global net product sales Submitted sBLA to FDA for VYVGART® Hytrulo for CIDP with priority review voucher (PRV); if approved, launch expected mid-2024 Reported positive data from Phase 2 ARDA study establishing proof-of-concept for empasiprubart in MMN Data from six Phase 2 proof-of-concep |
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| January 8, 2024 |
Exhibit 99.2 argenx The Next Chapter JP MORGAN HEALTHCARE CONFERENCE JANUARY 8, 2024 1 Forward Looking Statements This presentation has been prepared by argenx SE (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company |
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| December 20, 2023 |
Exhibit 99.1 argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus ● ADDRESS study did not meet primary or secondary endpoints ● Pemphigus deprioritized as efgartigimod indication ● Update on BALLAD study GO/NO GO decision ● Conference call scheduled for today, December 20, 2023, at 8:30am ET (2:30pm CET) Regulated Information – Inside Information December 2 |
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| December 20, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of December 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| November 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of November 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| November 28, 2023 |
Exhibit 99.1 argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia - Study did not meet primary or secondary endpoints - Favorable safety and tolerability profile consistent with previous clinical trials - Conference call scheduled for today, November 28, 2023 at 8:30am ET (2:30pm CET) Regulated information – Ins |
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| November 17, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of November 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| November 17, 2023 |
Exhibit 99.1 argenx Announces European Commission Approval of Subcutaneous VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis VYVGART® is now approved for both intravenous (IV) and self-administered subcutaneous (SC) use in Europe argenx is committed to continued collaboration with local authorities across the region to enable broad access to VYVGART SC for eligible patients Amsterdam, |
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| November 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of November 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| November 1, 2023 |
Exhibit 99.1 argenx Highlights Data Evaluating VYVGART in Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions Long-term clinical trial and real-world data illustrate VYVGART® drives consistent, repeatable and clinically meaningful responses, including minimal symptom expression (MSE) in generalized myasthenia gravis (gMG) Patients treated with VYVGART experienced consistent impr |
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| October 31, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of October 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive of |
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| October 31, 2023 |
Exhibit 99.2 Third Quarter 2023 Financial Results and Business Update October 31, 2023 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company |
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| October 31, 2023 |
Exhibit 99.1 argenx Reports Third Quarter 2023 Financial Results and Provides Business Update - $329 million in third quarter global net product sales - On track to submit VYVGART® Hytrulo sBLA for CIDP by year-end 2023 - Results from the ADVANCE-IV study published in The Lancet - Management to host conference call today at 1:30 pm CET (8:30 am ET) October 31, 2023 Amsterdam, the Netherlands – arg |
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| September 27, 2023 |
EQUITY INCENTIVE PLAN 2023 as approved by the board of directors of argenx SE on 2 May 2023 Exhibit 99.2 EQUITY INCENTIVE PLAN 2023 as approved by the board of directors of argenx SE on 2 May 2023 1. INTRODUCTION 1.1. PURPOSE Our mission is to transform patients’ lives by providing them with life-changing medicines which build on scientific breakthroughs in immunology. Our future success is largely dependent on our ability to attract and retain highly qualified individuals such as you, a |
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| September 27, 2023 |
As filed with the U.S. Securities and Exchange Commission on September 27, 2023 As filed with the U.S. Securities and Exchange Commission on September 27, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ARGENX SE (Exact name of registrant as specified in its charter) The Netherlands Not applicable (State or other jurisdiction of incorporation or organization) (I |
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| September 27, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) ARGENX SE (Exact Name of Registrant as Specified in its Charter) Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee (3) Equity Ordinary shares, nominal value of €0. |
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| September 21, 2023 |
Exhibit 99.1 argenx Announces VYVGART (efgartigimod alfa) Authorized for Sale by Health Canada for Generalized Myasthenia Gravis ● VYVGART ® is the first-and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada ● Approval based on the positive Phase 3 ADAPT trial (p<0.001) showing 68% of VYVGART-treated patients were responders on the MG-ADL scale compared to 30% of placebo pat |
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| September 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of September 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive |
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| July 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| July 27, 2023 |
Table of Contents TABLE OF CONTENTS UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION 2 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS 4 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME AND LOSS 5 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS 6 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGE |
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| July 27, 2023 |
Exhibit 99.1 argenx Reports Half Year 2023 Financial Results and Provides Second Quarter Business Update - $269 million in second quarter VYVGART® (efgartigimod alfa-fcab) global net product sales - VYVGART® Hytrulo now available in the U.S. with first vials shipped in July - Global VYVGART expansion continued with commercial launch in Italy and distribution agreement with Handok in South Korea - |
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| July 21, 2023 |
Exhibit 1.1 ARGENX SE 2,244,899 Ordinary Shares (including 1,580,981 American Depositary Shares, each Representing One Ordinary Share) UNDERWRITING AGREEMENT July 18, 2023 J.P. Morgan Securities LLC Morgan Stanley & Co. LLC Goldman Sachs & Co. LLC BofA Securities, Inc. Cowen and Company, LLC as Representatives of the several Underwriters named in Schedule A hereto c/o J.P. Morgan Securities LLC 38 |
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| July 21, 2023 |
argenx announces launch of proposed global offering Exhibit 99.1 Regulated information — Inside information argenx announces launch of proposed global offering July 17, 2023 Amsterdam, the Netherlands — argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced today that it has commenced a global offering of $750 million (approximately €668.6 mill |
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| July 21, 2023 |
argenx raises $1.1 billion in gross proceeds in a global offering Exhibit 99.2 Regulated information — Inside information argenx raises $1.1 billion in gross proceeds in a global offering July 18, 2023, 9:20 PM ET July 19, 2023, 3:20 AM CET Amsterdam, the Netherlands — argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced today the pricing of a global offer |
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| July 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| July 20, 2023 |
Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) ARGENX SE (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee(2) Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity Ordinary Shares, nominal value of €0. |
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| July 20, 2023 |
TABLE OF CONTENTS Filed Pursuant to Rule 424(b)(5) Registration No. 333-258251 Prospectus supplement (To prospectus dated July 29, 2021) 2,244,899 Ordinary shares (Including ordinary shares represented by American depositary shares) We are offering 2,244,899 ordinary shares (including ordinary shares represented by American Depositary Shares, or ADSs), in a global offering. We are offering ord |
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| July 17, 2023 |
Exhibit 99.1 argenx Reports Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy - Study met primary endpoint (p=0.000039); VYVGART® Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in risk of relapse versus placebo - IgG autoantibodies shown to play significant role in underlying CIDP disease biology - Favora |
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| July 17, 2023 |
TABLE OF CONTENTS The information in this preliminary prospectus supplement is not complete and may be changed. |
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| July 17, 2023 |
ADHERE Study T opline Results July 17 , 2023 Exhibit 99.2 ADHERE Study T opline Results July 17 , 2023 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, ag |
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| July 17, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| June 30, 2023 |
Exhibit 99.1 argenx and Zai Lab Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China ● First-and-only approved FcRn antagonist for gMG patients by NMPA ● 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with 30% of patients trea |
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| June 21, 2023 |
Regulated Information/Inside Information Exhibit 99.1 argenx initiates second cohort of Phase 2 ARDA study of empasiprubart in multifocal motor neuropathy · Independent Data Monitoring Committee recommended study continuation based on the favorable safety profile observed in the first dose cohort · Early efficacy signals support proof-of-concept of empasiprubart in multifocal motor neuropathy Regulated Information/Inside Information Amst |
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| June 21, 2023 |
Regulated Information/Inside Information Exhibit 99.2 argenx Announces U.S. Food and Drug Administration Approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis • VYVGART® Hytrulo is first FDA-approved subcutaneous (SC) injectable for generalized myasthenia gravis (gMG) • With this approval, argenx broadens innovative gMG product offering and demonstrates cont |
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| June 21, 2023 |
Exhibit 99.3 VYVGART ® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) FDA Approval Call June 21, 2023 2 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the pres |
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| June 21, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offic |
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| May 5, 2023 |
Annual general meeting of argenx SE May 2, 2023 – Voting results Exhibit 99.2 Annual general meeting of argenx SE May 2, 2023 – Voting results Total number of outstanding shares at the record date. 55,685,883 Total shares present or represented at the AGM. 46,781,165 Percentage represented share capital at AGM. 84.01 % Total valid votes at AGM. 46,781,165 Agenda Item Resolution 3 Advisory vote on the 2022 remuneration report. Votes for 20,460,533 (44.14%) Votes |
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| May 5, 2023 |
argenx announces results of Annual General Meeting of Shareholders Exhibit 99.1 argenx announces results of Annual General Meeting of Shareholders May 3, 2023 Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the results of its annual general meeting of shareholders held yesterday. All items on the agenda received a majority |
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| May 5, 2023 |
Exhibit 99.2 First Quarter 2023 Financial Results and Business Update May 4, 2023 2 Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or |
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| May 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive office |
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| May 5, 2023 |
Exhibit 99.1 argenx Reports First Quarter 2023 Financial Results and Provides Business Update - $218 million in first quarter VYVGART® (efgartigimod alfa-fcab) global net product sales - VYVGART received marketing authorization in Israel through partnership with Medison - 88 events achieved in ADHERE trial; topline data now expected in July 2023 - Enrollment completed in ADVANCE-SC and ADDRESS tri |
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| May 5, 2023 |
6-K 1 tm2314617d26k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Addr |
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| April 18, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| April 18, 2023 |
Exhibit 99.1 argenx Demonstrates Commitment to Redefining Treatment Goals for Generalized Myasthenia Gravis with Multiple Presentations at American Academy of Neurology 2023 Annual Meeting Amsterdam, the Netherlands – 04/18/2023 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that |
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| April 17, 2023 |
6-K 1 tm2312788d16k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Ad |
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| April 17, 2023 |
argenx and Genmab Enter Partnership to Advance Antibody Therapies in Immunology and Oncology Exhibit 99.1 argenx and Genmab Enter Partnership to Advance Antibody Therapies in Immunology and Oncology • Genmab and argenx have entered into a multiyear collaboration bringing together capabilities to jointly discover, develop and commercialize antibody therapies • Discovery programs against two differentiated targets are underway Amsterdam, the Netherlands – 04/17/2023 argenx SE (Euronext & Na |
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| March 16, 2023 |
Exhibit 4.9 REMUNERATION POLICY 2021 approved at our general meeting of 11 May 2021 1.INTRODUCTION AND KEY PRINCIPLES - attract, retain and motivate superior talent to serve on our senior leadership team by offering market competitive remuneration packages that are strategically aligned in the regions in which we operate; - promote long-term value creation over short-term success through co-owners |
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| March 16, 2023 |
Exhibit 12.2 CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Karl Gubitz, certify that: 1. I have reviewed this Annual Report on Form 20-F of argenx SE; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material f |
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| March 16, 2023 |
Articles of Association (English translation), as amended Exhibit 1.1 Unofficial translation of the articles of association of argenx SE as they read after the execution of a deed of partial amendment of the articles of association before Dirk-Jan Jeroen Smit, civil law notary in Amsterdam, the Netherlands, on 10 May 2022. Please note that this is an unofficial office translation, in which an attempt has been made to be as literal as possible without jeo |
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| March 16, 2023 |
Exhibit 99.1 argenx Announces UK MHRA Approval of VYVGART for the Treatment of Generalized Myasthenia Gravis VYVGART is the first neonatal Fc receptor (FcRn) blocker approved in the UK for the treatment of adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive 68% of anti-AChR antibody positive gMG patients treated with VYVGART were resp |
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| March 16, 2023 |
Consent of Deloitte Accountants B.V. Exhibit 15.1 Consent of independent registered public accounting firm We consent to the incorporation by reference in Registration Statements 333-258253 and 333-225375 on Form S-8 and Registration Statement No. 333-258251 on Form F-3 of our reports dated March 16, 2023, relating to the financial statements of argenx SE and the effectiveness of argenx SE’s internal control over financial reporting, |
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| March 16, 2023 |
Exhibit 12.1 CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Tim Van Hauwermeiren, certify that: 1. I have reviewed this Annual Report on Form 20-F of argenx SE; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a m |
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| March 16, 2023 |
Argenx Equity Incentive Plan 2021 Exhibit 4.4 EQUITY INCENTIVE PLAN 2021 as approved by the board of directors of argenx SE on 15 December 2021 1.INTRODUCTION 2.GRANTING EQUITY INCENTIVES 1.1.PURPOSE 2.1.ELIGIBILITY TO PARTICIPATE IN THIS PLAN Our mission is to transform patients’ lives by providing them with life-changing medicines which build on scientific breakthroughs in immunology. Our future success is largely dependent on o |
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| March 16, 2023 |
Exhibit 2.3 DESCRIPTION OF SHARE CAPITAL argenx SE (company, argenx, we, us, and our) has one class of securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (Exchange Act): ordinary shares, including ordinary shares represented by American Depositary Shares (ADSs). The following description is a summary of certain information relating to our share capit |
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| March 16, 2023 |
Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 20-F of argenx SE (the “Company”) for the fiscal year ended December 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursu |
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| March 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF |
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| March 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 16, 2023 |
Rules for the Board of Directors Exhibit 1.2 RULES (BY-LAWS) FOR THE BOARD OF DIRECTORS OF ARGENX SE as approved by the board of directors of argenx SE on 2 March 2021 1. STATUS OF THESE RULES These rules of the board of directors (the "Rules") have been established by the board of directors pursuant to article 10, paragraph 4 of the Articles of Association. These Rules are supplementary to the provisions concerning the board of |
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| March 16, 2023 |
Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 20-F of argenx SE (the “Company”) for the fiscal year ended December 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursu |
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| March 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive offi |
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| March 2, 2023 |
Fourth Quarter and Full Year 2022 Financial Results and Business Update March 2, 2023 Exhibit 99.3 Fourth Quarter and Full Year 2022 Financial Results and Business Update March 2, 2023 2 Forward Looking Statements This presentation has been prepared by argenx se (“ argenx ” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter |
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| March 2, 2023 |
Exhibit 99.2 argenx Reports Full Year 2022 Financial Results and Provides Fourth Quarter Business Update $173 million in fourth quarter and $401 million in full year 2022 VYVGART® (efgartigimod alfa-fcab) global net product sales FDA review ongoing for SC efgartigimod BLA with PDUFA target action date of June 20, 2023; MAA filed in Japan with approval decision expected by first quarter of 2024 ADH |
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| March 2, 2023 |
argenx Announces Planned Transition of Chief Operating Officer Exhibit 99.1 argenx Announces Planned Transition of Chief Operating Officer · Karen Massey appointed as Chief Operating Officer, effective March 13, 2023 · Keith Woods to retire and serve as Advisor on argenx Board of Directors March 2, 2023 Amsterdam, the Netherlands — argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe au |
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| February 10, 2023 |
ARGX / argenx SE ADS / Artisan Partners Limited Partnership - SC 13G/A Passive Investment SC 13G/A 1 d443982dsc13ga.htm SC 13G/A SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G (Rule 13d-102) Information to be Included in Statements Filed Pursuant to Rule 13d-1(b), (c) and (d) and Amendments Thereto Filed Pursuant to Rule 13d-2. Under the Securities Exchange Act of 1934 (Amendment No. 1)* Argenx SE (Name of Issuer) American Depositary Shares (Title of Class of Se |
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| January 30, 2023 |
PROXY FORM EXTRAORDINARY GENERAL MEETING ARGENX SE 27 FEBRUARY 2023 Exhibit 99.5 PROXY FORM EXTRAORDINARY GENERAL MEETING ARGENX SE 27 FEBRUARY 2023 IMPORTANT NOTICE: for the extraordinary meeting February 2023 argenx uses the e-voting system of ABN AMRO. The company therefore kindly requests all shareholders who wish to vote at the general meeting but cannot/do not wish to attend, to use the proxy/e-voting services of ABN via HTTPS://WWW.ABNAMRO.SECURITIESVOTING. |
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| January 30, 2023 |
EXTRAORDINARY GENERAL MEETING OF ARGENX SE OF 27 FEBRUARY 2023 Exhibit 99.4 EXTRAORDINARY GENERAL MEETING OF ARGENX SE OF 27 FEBRUARY 2023 AGENDA 1. Opening 2. Appointment of Steve Krognes as non-executive director to the board of directors of the Company (voting item) 3. Any other business, announcements or questions 4. End of the extraordinary general meeting argenx SE Laarderhoogtweg 25, 1101 EB Amsterdam, the Netherlands [email protected] – www.argenx.com |
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| January 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive of |
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| January 30, 2023 |
EXTRAORDINARY GENERAL MEETING OF ARGENX SE Exhibit 99.2 EXTRAORDINARY GENERAL MEETING OF ARGENX SE CONVOCATION argenx SE (the "Company") hereby invites its shareholders and all other persons with meeting rights to attend its extraordinary general meeting of shareholders ("EGM") to be held at 12:00 PM CET on Monday afternoon, February 27, 2023 at Hilton Hotel Schiphol, Schiphol Boulevard 701, 1118 BN Schiphol, the Netherlands. We would like |
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| January 30, 2023 |
EXTRAORDINARY GENERAL MEETING OF ARGENX SE EXPLANATORY NOTES Exhibit 99.3 EXTRAORDINARY GENERAL MEETING OF ARGENX SE EXPLANATORY NOTES The following item on the agenda of the extraordinary general meeting of argenx SE (the "Company") shall be discussed and/or put to a vote. The number in the list correspond to the number on the agenda. 2. Appointment of Steve Krognes as non-executive director to the board of directors of the Company (voting item) The Board |
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| January 30, 2023 |
Exhibit 99.1 argenx Announces Extraordinary General Meeting of Shareholders on February 27, 2023 to Appoint Steve Krognes as Non-Executive Director January 16, 2023 Amsterdam, the Netherlands — argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced an extraordinary general meeting of sha |
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| January 27, 2023 |
argenx Receives Notification of PDUFA Date Extension for SC Efgartigimod Exhibit 99.1 argenx Receives Notification of PDUFA Date Extension for SC Efgartigimod January 27, 2023 Amsterdam, the Netherlands — argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the Biologics License Applic |
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| January 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive of |
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| January 9, 2023 |
Exhibit 99.1 argenx Highlights 2023 Strategic Priorities Across Immunology Pipeline Reported $402 million in preliminary* full-year 2022 global net VYVGART sales ADHERE topline results now expected in second quarter of 2023; Stage B enrollment has surpassed projected target of 130 patients Registrational trial of efgartigimod in thyroid eye disease (TED) to start in 2023; additional proof-of-conce |
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| January 9, 2023 |
J.P. Morgan Healthcare Conference January 2023 Exhibit 99.2 J.P. Morgan Healthcare Conference January 2023 2 Forward Looking Statements This presentation has been prepared by argenx se (“ argenx ” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employ |
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| January 9, 2023 |
6-K 1 tm232678d16k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2023 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (A |
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| December 12, 2022 |
Exhibit 99.1 argenx to Present Pivotal ADVANCE Trial Data During ASH Plenary Session Highlighting VYVGART? (efgartigimod alfa-fcab) as Potential New Treatment Modality for Immune Thrombocytopenia First immune thrombocytopenia (ITP) plenary selection in 15 years underscores significant unmet need in this rare, serious autoimmune bleeding disease VYVGART showed rapid, clinically and statistically si |
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| December 12, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of December 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| November 30, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of November 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Laarderhoogtweg 25 1101 EB Amsterdam, the Netherlands (Address of principal executive o |
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| November 30, 2022 |
Asset Purchase Agreement, dated November 29, 2022, by and between bluebird bio, Inc. and argenx BV ? Exhibit 1.1 ? ASSET PURCHASE AGREEMENT ? This ASSET PURCHASE AGREEMENT (this ?Agreement?) is made and entered into as of November 29, 2022 (the ?Effective Date?), by and between Bluebird Bio, Inc., a corporation organized under the laws of Delaware (?Seller?), and ARGENX BV, a limited liability company organized under the laws of Belgium (?Buyer?). Buyer and Seller may hereinafter be referred to |
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| November 30, 2022 |
argenx Enters Into Agreement To Acquire Priority Review Voucher Exhibit 99.1 argenx Enters Into Agreement To Acquire Priority Review Voucher Amsterdam, the Netherlands ? November 30, 2022 ? argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced an agreement to acquire a U.S. Food and Drug Administration (FDA) Priority Review Voucher (PRV) for $102 mi |
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| November 22, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of November 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) |
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| November 22, 2022 |
Exhibit 99.1 argenx Announces U.S. FDA Acceptance of Biologics License Application for Subcutaneous Efgartigimod in Generalized Myasthenia Gravis with Priority Review - Prescription Drug User Fee Act (PDUFA) target action date is March 20, 2023 - Submission based on positive results from the Phase 3 bridging study demonstrating noninferior total IgG reduction at day 29 with subcutaneously (SC) adm |
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| October 27, 2022 |
Exhibit 99.1 argenx Reports Third Quarter 2022 Financial Results and Provides Business Update - $131 million in third quarter VYVGART® (efgartigimod alfa-fcab) global net product sales - Filed Biologics License Application (BLA) for subcutaneous (SC) efgartigimod for treatment of generalized myasthenia gravis (gMG) - Hans de Haard, Ph.D. to retire as Chief Scientific Officer (CSO) in January 2023 |
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| October 27, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of October 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant’s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) |
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| September 21, 2022 |
Exhibit 99.2 argenx to Highlight Key Programs from Neuromuscular Franchise at Upcoming Medical Meetings Scientific presentations demonstrate argenx?s leadership in FcRn blockade and commitment to innovating for patients across multiple neuromuscular diseases Additional data from ADAPT+ open-label study support long-term safety of VYVGART? (efgartigimod alfa-fcab) for treatment of adult patients wi |
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| September 21, 2022 |
Exhibit 99.1 argenx Submits Biologics License Application to U.S. Food and Drug Administration for Subcutaneous Efgartigimod for Treatment of Generalized Myasthenia Gravis ? Submission package based on positive data from the Phase 3 ADAPT-SC trial demonstrating noninferiority of subcutaneous (SC) efgartigimod compared to intravenously administered VYVGART? (efgartigimod alfa-fcab) based on total i |
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| September 21, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of September 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices |
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| September 8, 2022 |
argenx Appoints Camilla Sylvest to Board of Directors Exhibit 99.1 argenx Appoints Camilla Sylvest to Board of Directors September 8, 2022 Amsterdam, the Netherlands ? argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that during the extraordinary general meeting of shareholders held today at 6:30pm CET, Mrs. Camilla Sylvest was appointed as no |
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| September 8, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of September 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices |
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| August 12, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of August 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) I |
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| August 12, 2022 |
Exhibit 99.1 argenx Announces European Commission Approval of VYVGART? (efgartigimod alfa-fcab) for the Treatment of Generalized Myasthenia Gravis VYVGART is the first neonatal Fc receptor (FcRn) blocker approved in Europe for the treatment of adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive 68% of anti-AChR antibody positive gMG p |
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| July 28, 2022 |
TABLE OF CONTENTS ? MANAGEMENT REPORT 2 1. MAIN EVENTS IN THE SIX MONTHS OF 2022 2 2. FINANCIAL HIGHLIGHTS 3 3. FINANCIAL GUIDANCE 4 4. RISK FACTORS 4 5. EXTERNAL IMPACTS 5 6. FORWARD-LOOKING STATEMENTS 5 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION 6 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT OR LOSS 8 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMEN |
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| July 28, 2022 |
? UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ? FORM 6-K ? ? REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 ? For the Month of July 2022 ? Commission File Number: 001-38097 ? ? ARGENX SE (Translation of registrant?s name into English) ? ? Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal ex |
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| July 28, 2022 |
Exhibit 99.1 ? ? ? ? argenx Reports Half Year 2022 Financial Results and Provides Second Quarter Business Update ? - $75 million in second quarter VYVGART? (efgartigimod alfa-fcab) global net product sales from U.S. and Japan commercial launch; approval in Europe on track for third quarter 2022 ? - Biologics License Application (BLA) for VYVGART accepted by China?s National Medical Products Admini |
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| June 27, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of June 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) Ind |
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| June 27, 2022 |
Exhibit 99.1 argenx Receives Positive CHMP Opinion for Efgartigimod for the Treatment of Adult Patients with Generalized Myasthenia Gravis in Europe ? Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures ? European Commission decision on marketing authorization application (MAA) expected in approxima |
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| May 19, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) Indi |
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| May 19, 2022 |
Exhibit 99.1 argenx Announces Publication of Translational Data of Efgartigimod in Autoimmune Skin Blistering Diseases - Translational data from Phase 2 study of efgartigimod in pemphigus further demonstrate argenx?s scientific leadership in FcRn biology, providing new insights into pathophysiology of autoimmune skin blistering diseases and potential role of FcRn blockade - Data to be included in |
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| May 5, 2022 |
Exhibit 99.2 argenx Announces Positive Phase 3 Data from ADVANCE Trial of VYVGART? (efgartigimod alfa-fcab) in Adults with Primary Immune Thrombocytopenia Study met primary endpoint, demonstrating a higher proportion of sustained platelet response with VYVGART treatment compared to placebo (p=0.0316); responders observed across patient types regardless of prior therapy or disease severity Statisti |
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| May 5, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) Indi |
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| May 5, 2022 |
Exhibit 99.1 argenx Reports First Quarter 2022 Financial Results and Provides Business Update -???????$21.2 million in VYVGART? (efgartigimod alfa-fcab) net product sales during initial quarter of U.S. commercial launch -??????Met primary endpoint in Phase 3 ADVANCE trial of VYVGART for treatment of primary immune thrombocytopenia (ITP) -??????Japan commercial launch of VYVGART on track to start t |
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| March 25, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) In |
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| March 25, 2022 |
argenx announces launch of proposed global offering Exhibit 99.1 Regulated information ? Inside information argenx announces launch of proposed global offering March 22, 2022 Breda, the Netherlands ? argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced today that it has commenced a global offering of $500 million (approximately ?453 million) |
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| March 25, 2022 |
Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) ARGENX SE (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price(1) Fee Rate Amount of Registration Fee(2) Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity Ordinary Shares, nominal value of ?0. |
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| March 25, 2022 |
argenx raises $700 million in gross proceeds in a global offering Exhibit 99.2 Regulated information ? Inside information argenx raises $700 million in gross proceeds in a global offering March 23, 2022, 8:30 PM ET March 24, 2022, 1:30 AM CET Breda, the Netherlands ? argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced today the pricing of a global offerin |
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| March 25, 2022 |
Exhibit 1.1 ARGENX SE 2,333,334 Ordinary Shares (including 1,433,701 American Depositary Shares, each Representing One Ordinary Share) UNDERWRITING AGREEMENT March 23, 2022 J.P. Morgan Securities LLC Morgan Stanley & Co. LLC Cowen and Company, LLC SVB Securities LLC as Representatives of the several Underwriters named in Schedule A hereto c/o J.P. Morgan Securities LLC 383 Madison Avenue New York, |
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| March 25, 2022 |
TABLE OF CONTENTS ?Filed Pursuant to Rule 424(b)(5)? ?Registration No. 333-258251? Prospectus supplement (To prospectus dated July 29, 2021) 2,333,334 Ordinary shares (Including ordinary shares represented by American depositary shares) We are offering 2,333,334 ordinary shares (including ordinary shares represented by American Depositary Shares, or ADSs), in a global offering. We are offering ord |
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| March 22, 2022 |
Exhibit 99.1 argenx Announces Positive Topline Phase 3 Data from ADAPT-SC Study Evaluating Subcutaneous Efgartigimod for Generalized Myasthenia Gravis - Study met primary endpoint, demonstrating noninferior total IgG reduction at day 29 with subcutaneously administered efgartigimod compared to intravenous (IV) administration - Secondary endpoints show clinical improvement consistent with IV admini |
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| March 22, 2022 |
Exhibit 99.2 Together We Discover Reaching Patients Through Immunology Innovation March 22, 2022 Topline Results: ADAPT - SC Bridging Study in gMG 1 Forward Looking Statements This presentation has been prepared by argenx se (? argenx ? or the ?company?) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommenda |
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| March 22, 2022 |
TABLE OF CONTENTS The information in this preliminary prospectus supplement is not complete and may be changed. |
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| March 22, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) In |
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| March 21, 2022 |
Exhibit 13.2 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 20-F of argenx SE (the “Company”) for the fiscal year ended December 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursu |
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| March 21, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F Table of Contents ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. |
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| March 21, 2022 |
Exhibit 13.1 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report on Form 20-F of argenx SE (the “Company”) for the fiscal year ended December 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursu |
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| March 21, 2022 |
Argenx Equity Incentive Plan 2021 Exhibit 4.4 EQUITY INCENTIVE PLAN 2021 as approved by the board of directors of argenx SE on 15 December 2021 1.INTRODUCTION 2.GRANTING EQUITY INCENTIVES ? ? ? 1.1.PURPOSE ? 2.1.ELIGIBILITY TO PARTICIPATE IN THIS PLAN ? ? ? Our mission is to transform patients? lives by providing them with life-changing medicines which build on scientific breakthroughs in immunology. Our future success is largely |
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| March 21, 2022 |
Consent of Deloitte Accountants B.V. Exhibit 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in Registration Statements No. 333-258253 and 333-225375 on Form S-8 and Registration Statement No. 333-258251 on Form F-3 of our reports dated March 21, 2022, relating to the financial statements of argenx SE and the effectiveness of argenx SE?s internal control over financial report |
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| March 21, 2022 |
Exhibit 12.2 CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Karl Gubitz, certify that: 1. I have reviewed this Annual Report on Form 20-F of argenx SE; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material f |
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| March 21, 2022 |
Exhibit 12.1 CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Tim Van Hauwermeiren, certify that: 1. I have reviewed this Annual Report on Form 20-F of argenx SE; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a m |
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| March 3, 2022 |
Exhibit 99.1 ?? ?????? ? ????argenx Reports Full Year 2021 Financial Results and Provides Fourth Quarter Business Update ?- VYVGART? (efgartigimod alfa-fcab) approved in the U.S. and Japan as the first-and-only neonatal Fc receptor (FcRn) blocker; U.S. commercial launch underway - Topline results from Phase 3 bridging study of subcutaneous (SC) efgartigimod in generalized myasthenia gravis (gMG) o |
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| March 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) In |
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| January 20, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) |
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| January 20, 2022 |
argenx announces VYVGART™ approval in Japan for the treatment of generalized myasthenia gravis Exhibit 99.1 argenx announces VYVGART™ approval in Japan for the treatment of generalized myasthenia gravis · VYVGARTTM (efgartigimod alfa) is the first-and-only FcRn blocker approved in Japan · Ministry of Health, Labour and Welfare (MHLW) decision marks second regulatory approval of VYVGART as part of global launch strategy, following approval in U.S. on December 17, 2021 Regulated Information/I |
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| January 10, 2022 |
Exhibit 99.1 Together We Discover J.P. Morgan Healthcare Conference January 10, 2022 Reaching Patients Through Immunology Innovation Forward Looking Statements This presentation has been prepared by argenx se (?argenx? or the ?company?) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or r |
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| January 10, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) |
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| January 7, 2022 |
Exhibit 99.1 argenx Highlights Strategic Priorities for 2022 Initiated global VYVGART™ (efgartigimod alfa-fcab) commercial launch Expect data from five registrational trials of efgartigimod by first quarter of 2023 Announcing four new efgartigimod indications to be initiated in 2022: membranous nephropathy, lupus nephritis, Sjogren’s syndrome, COVID-19 mediated postural orthostatic tachycardia syn |
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| January 7, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of January 2022 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) |
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| December 22, 2021 |
Exhibit 99.1 argenx Announces U.S. Food and Drug Administration (FDA) Approval of VYVGART? (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis ? VYVGART is the first-and-only FDA-approved neonatal Fc receptor blocker ? 68% of anti-acetylcholine receptor (AChR) antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis - Activities of Daily Living ( |
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| December 22, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of December 2021 Commission File Number: 001-38097 ARGENX SE (Translation of registrant?s name into English) Willemstraat 5 4811 AH, Breda, the Netherlands (Address of principal executive offices) |
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| July 29, 2021 |
Exhibit 4.5 ARGENX SE TO Trustee Indenture Dated as of , 20 Subordinated Debt Securities TABLE OF CONTENTS Page ARTICLE ONE - DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION 1 SECTION 101. Definitions 1 SECTION 102. Compliance Certificates and Opinions 9 SECTION 103. Form of Documents Delivered to Trustee 9 SECTION 104. Acts of Holders 9 SECTION 105. Notices, etc., to Trustee and Company 1 |
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| July 29, 2021 |
Exhibit 99.1 ? ? argenx Reports Half Year 2021 Financial Results and Provides Second Quarter Business Update ? ? Completion of enrollment expected by year-end for ADAPT-SC and ADVANCE (IV) trials of efgartigimod; topline data for both trials expected in first half of 2022 ? Introduced ?argenx 2025? vision during R&D Day to highlight commitment to patients and science and outline path to becoming g |
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| July 29, 2021 |
As filed with the U.S. Securities and Exchange Commission on July 29, 2021 As filed with the U.S. Securities and Exchange Commission on July 29, 2021 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ARGENX SE (Exact name of registrant as specified in its charter) The Netherlands Not applicable (State or other jurisdiction of incorporation or organization) (I.R.S. |
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| July 29, 2021 |
Articles of Association, as amended (English translation) Exhibit 4.1 Unofficial translation of the articles of association of argenx SE as they read after the execution of a deed of partial amendment of the articles of association before Dirk-Jan Jeroen Smit, civil law notary in Amsterdam, the Netherlands, on 24 January 2020. Please note that this is an unofficial office translation, in which an attempt has been made to be as literal as possible without |
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| July 29, 2021 |
? TABLE OF CONTENTS MANAGEMENT REPORT?2 1. MAIN EVENTS IN THE SIX MONTHS OF 2021?2 2. FINANCIAL HIGHLIGHTS?3 3. FINANCIAL GUIDANCE?4 4. RISK FACTORS?4 5. FORWARD-LOOKING STATEMENTS?5 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION?6 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT AND LOSS?8 UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE PR |
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| July 29, 2021 |
Forms F-3 (File No. 333-258251) TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on July 29, 2021 Registration No. 333-????????? ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ? FORM F-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933? ? ARGENX SE (Exact name of Registrant as specified in its Charter) Not Applicable (Translation of registrant?s name into English) ? |
