Welcome to our dedicated page for Argenx Se news (Ticker: ARGX), a resource for investors and traders seeking the latest updates and insights on Argenx Se stock.
argenx SE (ARGX) is a global immunology company listed on Euronext and Nasdaq that focuses on severe autoimmune diseases through antibody-based medicines. Its news flow centers on clinical data, regulatory milestones, commercial performance and strategic updates related to its FcRn-targeting medicine VYVGART and a broader pipeline of experimental antibodies.
Investors and healthcare observers following ARGX news can read about regulatory interactions such as the U.S. Food and Drug Administration’s acceptance for priority review of a supplemental Biologics License Application (sBLA) for VYVGART in acetylcholine receptor antibody seronegative generalized myasthenia gravis (gMG). Company announcements also cover Phase 3 trial readouts, including the ADAPT SERON study in seronegative gMG and other registrational programs across neuromuscular and autoimmune indications.
argenx regularly reports preliminary and quarterly financial results, highlighting global product net sales from the VYVGART franchise and outlining strategic priorities tied to its long-term "Vision 2030". News items describe the expansion of VYVGART and VYVGART Hytrulo across gMG, chronic inflammatory demyelinating polyneuropathy (CIDP) and immune thrombocytopenia (ITP) in certain regions, as well as progress with pipeline candidates such as empasiprubart and ARGX-119.
Corporate news includes leadership transitions, conference presentations at major medical and investor meetings, and updates from the company’s Immunology Innovation Program (IIP). For readers interested in ARGX stock and the evolution of its immunology franchise, this news feed provides a consolidated view of clinical, regulatory, commercial and corporate developments as disclosed in argenx press releases and related filings.
argenx SE (Euronext & Nasdaq: ARGX) has announced its Annual General Meeting of shareholders, scheduled for May 27, 2025, at 13:00 CET. The meeting will take place at the Hilton Amsterdam Schiphol.
The agenda includes standard items such as the discussion and adoption of 2024 annual accounts, advisory vote on the 2024 remuneration report, discharge of directors, and authorization for the Board to issue shares and handle pre-emptive rights. Key proposals include the re-appointment of Anthony Rosenberg as a non-executive director and the adoption of a new remuneration policy.
Shareholders are encouraged to use voting by electronic proxy. All meeting documents and the company's 2024 annual report are available on argenx's website and www.abnamro.com/evoting.
argenx has received FDA approval for VYVGART Hytrulo prefilled syringe as a self-injection option for treating adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The new administration method allows for a 20-to-30-second subcutaneous injection that can be self-administered by patients after proper training.
This first-in-class FcRn blocker now offers three administration options, providing patients flexibility to receive treatment at home, while traveling, or in healthcare settings. The approval is supported by bioequivalence studies comparing the prefilled syringe to VYVGART Hytrulo in a vial, along with human factors validation studies demonstrating safe administration by patients and caregivers.
The company's patient support program, My VYVGART Path, offers resources including disease education, access support, benefits verification, and financial assistance for eligible patients.
argenx (ARGX) presented significant data at the AAN 2025 Annual Meeting, highlighting the sustained efficacy of VYVGART in treating generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
The ADAPT-NXT study showed that 75% of gMG patients achieved sustained improvement, with 56.5% reaching minimal symptom expression. The ADHERE+ data demonstrated VYVGART Hytrulo's long-term efficacy in CIDP patients, with 50% of relapsed patients restabilizing by week 4.
The company also revealed promising first-in-human data for ARGX-119, their third clinical candidate for neuromuscular junction disorders. Additionally, argenx is expanding VYVGART's applications through two Phase 3 studies: ADAPT-SERON for seronegative gMG and ADAPT-OCULUS for ocular MG.
argenx (ARGX) presented clinical trial and real-world data for VYVGART® and VYVGART® Hytrulo at the American Academy of Neurology Annual Meeting 2025. The data demonstrates consistent, favorable safety profiles and sustained clinical improvements for patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Key highlights include:
- ADAPT-NXT data showed sustained clinical improvements through 126 weeks with biweekly or three-week dosing
- ADAPT-SC+ analyses demonstrated consistent safety and sustained efficacy through nine treatment cycles
- Comparative effectiveness study revealed VYVGART shows more favorable benefit-risk profile among immunomodulatory therapies
- ADHERE+ interim results support long-term efficacy and functional improvement in CIDP patients
- Phase 4 trial investigating transition from IVIg to VYVGART Hytrulo within one week
argenx reported strong financial results for 2024, with global product net sales reaching $737 million in Q4 and $2.2 billion for the full year. The company received positive CHMP recommendation for VYVGART pre-filled syringe for gMG in the EU, with FDA decisions expected by April 10, 2025.
The company surpassed 10,000 patients across three indications with VYVGART and expects to become profitable in 2025. argenx is advancing its Vision 2030 strategy, aiming to treat 50,000 patients globally, secure 10 labeled indications, and advance five pipeline candidates to Phase 3.
Key developments include 20 ongoing clinical studies (10 Phase 3 and 10 Phase 2) across their pipeline in 2025. The company recognized a one-time tax benefit of $725 million related to previously unrecognized deferred tax assets. Full-year 2024 profit was $833 million, compared to a loss of $295 million in 2023.
argenx, a global immunology company focused on improving lives of people with severe autoimmune diseases, has announced that Tim Van Hauwermeiren, Chief Executive Officer, will present at the TD Cowen 45th Annual Healthcare Conference. The presentation is scheduled for Monday, March 3, 2025 at 11:50 a.m. ET.
Investors and interested parties can access a live webcast of the presentation through the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will remain available on the company website for approximately 30 days following the presentation.
argenx is listed on both Euronext and Nasdaq under the ticker symbol ARGX.
argenx (Euronext & Nasdaq: ARGX), a global immunology company focused on severe autoimmune diseases, has announced it will host a conference call and audio webcast on Thursday, February 27, 2025, at 2:30 PM CET (8:30 AM ET) to discuss its full year 2024 financial results and provide a fourth quarter business update.
The webcast will be accessible through the Investors section of the argenx website, with a replay available for approximately one year. The company has provided international dial-in numbers for Belgium, France, Netherlands, United Kingdom, United States, Japan, and Switzerland, with access code 3810049 for participants to join the call.
argenx reported preliminary global product net sales of $2.2 billion for full-year 2024, including $737 million in Q4 sales. The company announced its 2025 strategic priorities, focusing on expanding VYVGART's global reach and launching VYVGART SC as a pre-filled syringe, with FDA PDUFA scheduled for April 2025.
The company plans to execute 10 registrational and 10 proof-of-concept studies across its pipeline products: efgartigimod, empasiprubart, and ARGX-119. Four new pipeline molecules will be advanced in 2025. argenx expects to transition to sustainable profitability in 2025, with projected R&D and SG&A expenses of approximately $2.5 billion.
As of December 31, 2024, argenx had approximately $3.4 billion in cash, cash equivalents, and current financial assets.
argenx (Euronext & Nasdaq: ARGX), a global immunology company focused on severe autoimmune diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Tim Van Hauwermeiren, the company's CEO, will deliver a presentation on Monday, January 13, 2025 at 9:45 a.m. PT.
The presentation will be accessible through a live webcast on the Investors section of the argenx website (argenx.com/investors). A replay option will remain available on the company's website for approximately 30 days after the presentation.
argenx announced that Japan's MHLW has approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The treatment is administered as a weekly 30-90 second subcutaneous injection that can be self-administered at home, making it the first FcRn blocker approved for CIDP treatment in Japan.
The approval is based on the ADHERE Study, which showed that 69% of VYVDURA-treated patients demonstrated clinical improvement, with a 61% reduction in relapse risk versus placebo. The study was the largest clinical trial for CIDP to date, with 99% of participants continuing in the extension phase.
This marks VYVDURA's third approved indication in Japan, following its earlier approval for generalized myasthenia gravis (gMG) in January 2024.