Welcome to our dedicated page for ARGENX SE SEC filings (Ticker: ARGX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
argenx SE filings document the regulatory record of a foreign private issuer commercializing antibody-based medicines for severe autoimmune diseases. Form 6-K reports furnish press releases, investor presentations, financial results, FDA label updates for VYVGART and VYVGART Hytrulo, and clinical data presentations for programs in myasthenia gravis, CIDP, multifocal motor neuropathy, and related neuromuscular disorders.
The filings also cover annual-report materials filed with Dutch and U.S. regulators, incorporation by reference into Form S-8 registration statements, annual general meeting notices and results, board appointments, remuneration and annual-account votes, and other governance matters. These disclosures provide the formal record for argenx's product sales, pipeline development, capital-market reporting, risk factors, and foreign-issuer status.
ARGENX SE (ARGX) completed the acquisition of Forte Biosciences, Inc. through a cash tender offer followed by a merger, making Forte a wholly owned subsidiary and removing its common stock from trading on the Nasdaq Capital Market. The deal brings FB102, a first-in-class anti-CD122 monoclonal antibody with clinical proof-of-concept in vitiligo and celiac disease, into the argenx immunology pipeline.
Through a subsidiary, argenx purchased all validly tendered Forte shares at $77.00 per share in cash. As of the tender expiration, 19,894,879 Forte shares had been validly tendered and not withdrawn, representing 87.13% of Forte’s issued and outstanding common stock together with shares already owned by argenx and its affiliates. All remaining Forte shares were converted into the right to receive the same cash amount per share in the subsequent merger. FB102 is being evaluated in Phase 2 celiac disease and Phase 1b alopecia areata studies, with data expected in the second half of 2026.
argenx SE reported positive topline results from the Phase 3 ALKIVIA trial of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. The study met its primary endpoint with p=0.0011, showing rapid, durable and multidimensional clinical benefit versus placebo over 52 weeks.
Clinical improvement was consistent across immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), with impact on both muscle and skin measures. In the 264-patient global study, efgartigimod was well-tolerated and its safety profile was consistent with prior experience. Detailed results will be presented at a future medical meeting, and efgartigimod is also being studied in other autoimmune rheumatologic diseases.
T. Rowe Price Associates, Inc. reports beneficial ownership of 2,675,457 ADRs of argenx SE as of June 30, 2026, representing 4.3% of the ADR class. The firm has sole voting power over 2,649,465 ADRs and sole dispositive power over 2,675,457 ADRs, with no shared voting or dispositive power.
The position is reported as ownership of 5 percent or less of the class. T. Rowe Price Associates, Inc. states that this report should not be construed as an admission of beneficial ownership and that such beneficial ownership is expressly denied.
argenx SE has scheduled an Extraordinary General Meeting of Shareholders for 15:00 CEST on September 17, 2026, at the offices of Freshfields LLP in Amsterdam. Shareholders and others entitled to attend are invited, with details on in-person, proxy and e-voting participation provided via the company’s and ABN AMRO’s websites.
The agenda includes two voting items: the proposed appointments of Mr. Thomas M. Brakel and Mr. Khurem Farooq as non-executive directors of the Board of Directors. All meeting materials are available online, for inspection at argenx’s offices, or by email request, and argenx encourages use of electronic proxy voting.
argenx SE has entered into a definitive agreement to acquire Forte Biosciences, Inc. through a cash tender offer at $77 per share, implying an equity value of approximately $2.2 billion and an 86% premium to Forte’s volume-weighted average price since July 9, 2026. A wholly owned argenx subsidiary will commence the offer, followed by a merger in which any untendered Forte shares will receive the same cash consideration, subject to a majority tender and expiration or termination of the Hart-Scott-Rodino waiting period and other customary conditions. The deal, expected to close in Q3 2026 and funded entirely with cash on hand, will add Forte’s lead anti-CD122 antibody FB102, which has positive Phase 1b data in vitiligo and celiac disease and potential in additional autoimmune indications, to argenx’s immunology pipeline.
argenx SE reported strong half-year 2026 results, led by VYVGART. Product net sales reached $1.5 billion in the second quarter, representing 60% year‑over‑year and 17% quarter‑over‑quarter growth, and $2.8 billion for the first six months of 2026.
Total operating income for the half‑year was $2.9 billion and operating profit $887 million, yielding profit of $838 million, up from $415 million a year earlier. Basic earnings per share were $13.47 versus $6.80. Cash, cash equivalents and current financial assets totaled $5.2 billion at June 30, 2026.
Commercially, argenx launched an expanded U.S. label for VYVGART and VYVGART Hytrulo covering all generalized myasthenia gravis serotypes and is advancing registrational studies in myositis, multifocal motor neuropathy and other autoimmune indications, with several topline readouts expected between the third quarter of 2026 and 2027.
argenx filed a Form 6-K to share a press release about an upcoming research and development webinar on autoimmune myositis. The event, titled “R&D Spotlight: Advancing FcRn Leadership into Autoimmune Myositis,” will take place on June 23, 2026, at 2:00pm ET.
The webinar will feature argenx management, scientific leaders and external experts, and will be webcast live on the company’s investor website, with a replay available for about one year. Supporting presentation slides and other materials will be posted on the Events & Presentations section of the argenx website.
argenx furnished a report highlighting new clinical data for its FcRn blocker efgartigimod (VYVGART) in autoimmune rheumatic diseases, including myositis and Sjogren’s disease, presented at the EULAR 2026 congress. The data come mainly from the ALKIVIA/ALKIVIA+ myositis program and the RHO/RHO+ Sjogren’s program, which suggest sustained clinical benefit and a favorable safety profile in open-label extension settings.
The company also described a broad development plan: the randomized Phase 2/3 ALKIVIA study in autoimmune myositis enrolled 240 patients, with topline Phase 3 results expected in the third quarter of 2026, and the ongoing Phase 3 UNITY trial in moderate to severe Sjogren’s disease with topline results expected in the second half of 2027. Additional activities include a Phase 2 study in systemic sclerosis, cross-indication safety analyses, and scientific education efforts, underscoring argenx’s focus on expanding efgartigimod into multiple serious autoimmune indications.
argenx SE reports that the U.S. FDA has approved a label expansion for its therapies VYVGART and VYVGART Hytrulo to treat all adult patients with generalized myasthenia gravis (gMG), regardless of serotype.
The decision is based on the Phase 3 ADAPT SERON study in 119 anti-acetylcholine receptor antibody–negative patients, where VYVGART produced rapid, significant and sustained symptom improvements and was well tolerated. The label now explicitly covers anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive and triple seronegative adults, addressing a historically underserved 20% of the gMG population.
argenx reported a very strong first quarter of 2026, driven by rapid growth of VYVGART. Product net sales reached $1.3 billion, up from $790 million a year earlier, representing 63% year-over-year growth. Total operating income was $1.3 billion, while operating profit rose to $394 million, compared with $139 million in 2025, reflecting margin expansion despite higher research, development and commercial spending.
Profit for the period more than doubled to $366 million from $169 million, with basic earnings of $5.90 per share versus $2.78 a year earlier. Cash, cash equivalents and current financial assets totaled $4.9 billion as of March 31, 2026, providing substantial financial flexibility.
argenx highlighted continued global uptake of VYVGART in generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, along with an active late-stage pipeline. Key upcoming milestones include an FDA decision on seronegative gMG by May 10, 2026, multiple Phase 3 and Phase 2 readouts between 2026 and 2027, and advancement of empasiprubart and other immunology candidates under its “Vision 2030” strategy.