Argenx Se Stock Price, News & Analysis

argenx (NASDAQ:ARGX) announced positive topline results from its ADAPT SERON phase 3 study of VYVGART® in AChR-Ab seronegative generalized myasthenia gravis (gMG) patients. The study achieved its primary endpoint with statistical significance (p=0.0068), demonstrating meaningful improvements in patients' daily living activities compared to placebo.

This marks the first global phase 3 study showing clinical benefits across all three seronegative subtypes: MuSK+, LRP4+, and triple seronegative. The company plans to submit a Supplemental Biologics License Application (sBLA) to the FDA by the end of 2025 to expand VYVGART's label. The drug maintained its established safety profile with no new concerns identified.

argenx (Nasdaq: ARGX) announced an upcoming R&D webinar focusing on their ARGX-119 program, scheduled for September 16, 2025, at 2:00pm ET. The event, titled "R&D Spotlight | Pioneering MuSK Biology with ARGX-119," marks the first in a mini-series highlighting the company's pipeline and R&D strategy.

The webinar will feature argenx management, scientific leadership, and key opinion leaders discussing the MuSK agonist program and its potential applications in treating neuromuscular diseases, including congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA). The presentation will be accessible through the company's investor relations website.

argenx (Nasdaq: ARGX) has announced a partnership with nine-time Grand Slam champion Monica Seles to raise awareness for myasthenia gravis (MG). For the first time, Seles is publicly sharing her 5-year journey with MG, a chronic autoimmune disease affecting over 120,000 people in the U.S.

The partnership will highlight the company's 'Go for Greater' MG patient support initiative at the 2025 U.S. Open Tennis Championships, where argenx serves as a premier Global sponsor. The initiative aims to connect MG patients with support resources and foster community engagement through the website mg-united.com.

argenx (NASDAQ:ARGX) reported strong Q2 2025 financial results, with global product net sales reaching $949 million, representing 97% year-over-year growth. The company achieved $245 million in quarterly profit, with earnings per share of $4.02.

VYVGART SC launch in CIDP has gained momentum with over 2,500 patients on treatment globally. The company announced positive proof-of-concept data for ARGX-119 in CMS, advancing to a registrational study. argenx maintains its Vision 2030 goal of treating 50,000 patients globally, securing 10 labeled indications, and advancing five pipeline candidates to Phase 3.

The company's R&D and SG&A guidance remains at $2.5 billion, with six registrational and six proof-of-concept readouts expected by end of 2026.

argenx (Euronext & Nasdaq: ARGX), a global immunology company, will host a conference call and audio webcast on Thursday, July 31, 2025 at 2:30 p.m. CET (8:30 a.m. ET) to discuss its half year 2025 financial results and second quarter business update.

The webcast will be accessible through the Investors section of the argenx website at argenx.com/investors, with a replay available for approximately one year. The company has provided international dial-in numbers and the access code 3810049 for participants, who are advised to dial in 15 minutes before the call.

argenx SE (Nasdaq: ARGX) announced plans to advance ARGX-119, their first-in-class agonist antibody targeting muscle-specific kinase (MuSK), to a registrational study for congenital myasthenic syndromes (CMS) following positive Phase 1b results.

The Phase 1b multicenter, randomized, double-blinded, placebo-controlled trial demonstrated a favorable safety and tolerability profile for ARGX-119. The study showed consistent improvements in DOK7-CMS patients across multiple efficacy measures throughout the 12-week study period, including Six-Minute Walk Test, Quantitative Myasthenia Gravis score, and Myasthenia Gravis Activities of Daily Living score.

The trial design included a 4:1 randomization to ARGX-119 or placebo, with an 11-month duration comprising screening, treatment, and follow-up periods. ARGX-119 represents the sixth successful molecule developed through argenx's Immunology Innovation Program (IIP), validating their collaborative discovery model.

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.