Argenx Se Stock Price, News & Analysis

argenx (ARGX), a global immunology company focused on severe autoimmune diseases, has announced its participation in the BofA Securities 2025 Health Care Conference. CEO Tim Van Hauwermeiren and other management team members will deliver a presentation on Tuesday, May 13, 2025, at 4:20 p.m. PT.

The presentation will be accessible through a live webcast on the Investors section of argenx's website at argenx.com/investors. A replay will remain available for approximately 30 days after the event.

argenx, a global immunology company focused on developing treatments for severe autoimmune diseases, has scheduled its first quarter 2025 financial results and business update conference call for May 8, 2025.

The conference call and audio webcast will take place at 2:30 p.m. CET (8:30 a.m. ET). Investors and interested parties can access the live webcast through the Investors section of the argenx website. A replay will remain available on the website for approximately one year.

For direct participation, the company has provided international dial-in numbers for multiple countries including:

• United States: 1 888 415 4250
• United Kingdom: 44 800 358 0970
• Belgium: 32 800 50 201
• Japan: 81 3 4578 9081

argenx has received a positive CHMP opinion recommending European Commission approval of VYVGART (efgartigimod alfa) for subcutaneous injection in treating chronic inflammatory demyelinating polyneuropathy (CIDP). The treatment represents the first novel mechanism of action for CIDP in over 30 years.

The recommendation is based on the ADHERE clinical trial, which demonstrated that 66.5% of patients showed clinical improvement. The study met its primary endpoint with a 61% reduction in relapse risk versus placebo. The treatment can be administered by patients, caregivers, or healthcare professionals, with an initial weekly dosing that may be adjusted to every other week based on clinical evaluation.

VYVGART showed consistent safety results with previous clinical studies, and 99% of trial participants continued into the open-label extension. The European Commission's final decision on marketing authorization is expected within approximately two months.

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.