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 reported third-quarter 2026 product net sales of $1.721 billion, up 54% year over year. Operating profit was $486 million, compared with $346 million a year earlier, while profit was $506 million versus $344 million. For the nine months ended September 30, 2026, product net sales were $4.534 billion and profit was $1.344 billion. Cash, cash equivalents and current financial assets totaled $3.7 billion as of September 30, 2026, after approximately $2.1 billion was paid for the Forte Biosciences acquisition, net of acquired cash.
Management expects combined R&D and SG&A expenses of approximately $4 billion for 2026, including Forte transaction-related costs. The FDA accepted VYVGART and VYVGART Hytrulo applications for pediatric gMG for priority review, with a PDUFA target action date in February 2027; an sBLA for VYVGART in ocular myasthenia gravis was submitted. An sBLA for VYVGART Hytrulo in IMNM is on track for submission by year-end 2026, and argenx plans an additional registrational study in dermatomyositis. FB102 is advancing to Phase 3 in celiac disease following positive Phase 2 results.
argenx SE announced that results from its Phase 3 ALKIVIA study of efgartigimod in autoimmune myositis will be presented as a late-breaking oral presentation at ACR Convergence 2026 on November 11, 2026.
The study met its primary endpoint in the combined IMNM and DM population: mean Total Improvement Score (TIS) improvement at Week 52 was 15.4 points greater with efgartigimod than placebo (47.95 versus 32.56; p=0.0011). Improvements were observed as early as Week 4 and sustained through 52 weeks. A greater proportion of patients in both subtypes reached TIS ≥ 40 with efgartigimod, and median time to that score was shorter. argenx described efgartigimod as well-tolerated, with a safety profile consistent with prior studies and its known profile.
argenx SE (ARGX) reported that its Phase 2 study of investigational FB102 in adults with celiac disease met its primary endpoint: change from baseline in the villus height-to-crypt depth ratio at Day 78 versus placebo during a gluten challenge (p=0.0176). The study enrolled 126 adults who had been symptom-free on a strict gluten-free diet for at least 12 months. Other efficacy measures, including intraepithelial lymphocyte density, a composite score and symptoms, were consistent with the primary endpoint. argenx plans to advance FB102 into Phase 3, and the FDA has granted it Fast Track Designation for celiac disease. FB102 safety was consistent with prior studies, with no new safety signals identified.
Separately, argenx will discontinue the Phase 3 UNITY study of efgartigimod SC in adults with moderate-to-severe Sjögren's disease. An Independent Data Monitoring Committee recommended stopping for futility after an interim analysis, concluding the study was unable to meet its primary endpoint. Safety was consistent with efgartigimod's established profile, with no new safety signals. argenx plans a comprehensive data analysis after study close and database lock.
argenx SE (ARGX) said it will present clinical, long-term and real-world data at the 2026 AANEM Annual Meeting and MGFA Scientific Session, scheduled for September 29 to October 2, 2026, in Orlando. The program covers VYVGART and VYVGART Hytrulo in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), as well as multifocal motor neuropathy, congenital myasthenic syndromes and idiopathic inflammatory myopathy. It also includes pipeline candidates empasiprubart and adimanebart.
Listed presentations include interim and long-term analyses, real-world studies and study designs. The product safety information states that VYVGART and VYVGART Hytrulo can cause serious allergic reactions and may increase infection risk; it also describes infusion- or injection-related reactions and common side effects.
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.