Argenx Se Stock Price, News & Analysis

argenx (ARGX) has received European Commission approval for VYVGART SC (efgartigimod alfa) as a monotherapy for treating adult CIDP patients after prior corticosteroid or immunoglobulin treatment. This marks the first novel treatment mechanism for CIDP in over 30 years. The approval is based on the ADHERE trial, where 66.5% of patients showed clinical improvement and demonstrated a 61% reduction in relapse risk versus placebo. VYVGART SC, available as a vial or prefilled syringe, can be self-administered weekly with potential adjustment to bi-weekly dosing. The treatment specifically targets the neonatal Fc receptor (FcRn) and showed consistent safety results with previous studies. This approval applies to all 27 EU Member States plus Iceland, Liechtenstein, and Norway, representing a significant advancement for CIDP patients who often experience severe mobility issues and disability.

argenx (ARGX) presented positive Phase 2 results for efgartigimod in treating myositis and Sjogren's disease at EULAR 2025. In the ALKIVIA myositis study, efgartigimod showed significant improvement in muscle strength with a mean Total Improvement Score of 50.45 vs 35.65 for placebo (P=0.0004). 79% of treated patients achieved moderate improvement and 34% achieved major improvement. For Sjogren's disease, the RHO study showed 45.5% of efgartigimod patients achieved improved outcomes vs 11.1% for placebo. The drug demonstrated sustained IgG reduction of ~60% and decreased disease-associated antibodies. The FDA granted Fast Track designation for efgartigimod in primary Sjogren's disease. Both studies showed favorable safety profiles, and Phase 3 trials (ALKIVIA and UNITY) are ongoing.

argenx (Nasdaq: ARGX), a global immunology company focused on severe autoimmune diseases, announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference. Karl Gubitz, the company's Chief Financial Officer, will engage in a fireside chat on Tuesday, June 10, 2025, at 8:40 AM ET in Miami, FL. The presentation will be accessible via live webcast through the Investors section of argenx's website at argenx.com/investors, with a replay available for approximately 30 days following the event.

argenx SE (Euronext & Nasdaq: ARGX) held its Annual General Meeting of shareholders on May 27, 2025, with 91.1% of the company's share capital represented. Most agenda items received majority approval, except for the remuneration policy (agenda item 5) which received 73.0% approval, falling short of the required 75% threshold.

Key approved resolutions included: the 2024 remuneration report (76.7% in favor), 2024 annual report and accounts (99.9% approval), re-appointment of Anthony Rosenberg as non-executive director (93.6% approval), and authorization for the Board to issue shares up to 10% of outstanding share capital (99.4% approval).

argenx (ARGX) reported strong Q1 2025 financial results with $790 million in global product net sales, representing 99% year-over-year growth. The company achieved profitability with $169.5 million in net income ($2.78 per share) compared to a loss in Q1 2024. Key developments include the launch of VYVGART Hytrulo pre-filled syringe for self-injection in US and Germany, and a positive CHMP opinion for VYVGART-SC in EU for CIDP. The company maintains its 'Vision 2030' strategy to reach 50,000 patients across 10 labeled indications. Operating expenses increased to $668.4 million, with R&D expenses at $309 million and SG&A at $276.2 million. The company reaffirmed its financial guidance of approximately $2.5 billion in combined SG&A and R&D expenses for 2025.

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.

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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

Participants should use access code 3810049 and connect 15 minutes before the call starts.

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.