argenex NASDAQ: ARGX reported third-quarter 2026 product net sales of $1.7 billion, up 54% from a year earlier and 13% sequentially, as patient growth in generalized myasthenia gravis, or MG, and chronic inflammatory demyelinating polyneuropathy, or CIDP, continued to support demand for VYVGART.
Chief Executive Officer Karen Massey said the company remains early in realizing VYVGART’s potential across its current indications while pursuing expansion opportunities in neurology and rheumatology. The company also highlighted its broader pipeline, including empasiprubart in multifocal motor neuropathy, or MMN, and FB-102 in celiac disease.
Sales Growth and Profitability
U.S. product net sales totaled $1.5 billion during the quarter, rising 16% from the prior quarter. Sales were $81 million in Japan, $158 million across other international markets, and $11 million from products supplied to Zai Lab in China. Management said U.S. net pricing was broadly consistent with prior quarters, while gross-to-net deductions were 22%.
Chief Financial Officer Karl Gubitz said the company generated operating profit of $486 million, representing a 28% operating margin. Excluding $150 million of Forte acquisition-related transaction costs, operating margin was 37%.
Total operating expenses were $1.3 billion. Combined research and development and selling, general and administrative expenses were $1.1 billion, up 22% sequentially. Excluding the Forte transaction costs, the increase was 5%, according to the company.
argenx ended the quarter with $3.7 billion in cash equivalents and current financial assets after paying a net $2.1 billion for the Forte acquisition. The company expects combined R&D and SG&A expenses of approximately $4 billion for 2026, incorporating Forte-related costs, investment in FB-102, pipeline development and commercial preparations following positive ALKIVIA results.
Gubitz said roughly half of the increase in 2026 expense expectations versus prior Street expectations relates to Forte, including the $150 million charge recorded in the third quarter and roughly $50 million in FB-102 operating costs for the remainder of the year. He said argenx expects to provide more expense clarity for 2027 at the JPMorgan healthcare conference, while cautioning investors not to assume another 45% year-over-year increase in spending.
VYVGART Growth in MG and CIDP
Chief Commercialization Officer Sandrine Piret-Gerard said both MG and CIDP continued to grow during the quarter, with neither indication showing a slowdown. In MG, she said the recent seronegative label expansion was a meaningful contributor to growth and had secured coverage for approximately 96% of covered lives.
Most payers have removed serotype testing from VYVGART coverage policies, simplifying prescribing for generalized MG patients, according to Piret-Gerard. About 10% of prescribers treating seronegative patients were new to VYVGART, and the company said experience in seronegative patients has increased use among acetylcholine receptor antibody-positive patients as well.
The company has submitted supplemental biologics license applications for pediatric and ocular MG. The pediatric MG application has a Prescription Drug User Fee Act date in February 2027. Massey said approval in ocular MG would extend VYVGART beyond generalized MG for the first time, while a VYVGART Hytrulo auto-injector is expected in the second half of 2027.
In CIDP, argenx said adoption continued to expand among both patients and prescribers. The company cited open-label extension data from ADHERE and ADHERE+ showing that nearly 40% of initial VYVGART responders reached an INCAT score of zero or one, indicating little to no functional disability. It also pointed to Phase IV data supporting a one-week transition from intravenous immunoglobulin, or IVIG.
Myositis, MMN and 2027 Launch Plans
argenx plans to file an sBLA for VYVGART in immune-mediated necrotizing myopathy, or IMNM, by year-end. The program has breakthrough therapy designation. Management described IMNM as an urgent unmet need, noting that patients can deteriorate rapidly and that there are no approved treatments. The company estimates approximately 20,000 people in the U.S. are living with IMNM.
Positive Phase III ALKIVIA results supported the IMNM filing, according to Massey. The data also showed clinically meaningful results in dermatomyositis, or DM, but the company said it will conduct an additional registrational study in DM after discussions with the Food and Drug Administration. Chief Medical Officer Luc Truyen said the prior study missed its primary endpoint in DM despite an effect size consistent with IMNM, and the FDA requested confirmatory evidence.
Management said argenx could have up to five U.S. launches in 2027, including potential MG label expansions, IMNM, the auto-injector and a possible MMN launch for empasiprubart.
The Phase III EMPASSION study of empasiprubart against IVIG in MMN is expected to read out in December. The company is not publicly disclosing the trial’s non-inferiority margin. Truyen said the study was designed to assess whether empasiprubart can match IVIG efficacy while reducing treatment burden, with superiority representing a potential additional outcome.
If results are positive, Massey said argenx plans to seek priority review, based on the unmet need in MMN. Piret-Gerard said non-inferiority to IVIG would be a successful outcome because MMN patients often require burdensome infusion schedules, while empasiprubart could initially be administered intravenously monthly and potentially transition to subcutaneous administration and an auto-injector over time.
Pipeline Expansion and Development Discipline
Beyond VYVGART and empasiprubart, argenx highlighted positive Phase II results for FB-102 in celiac disease following the Forte acquisition. Management said the results were consistent across efficacy measures, including symptoms and histology, and showed a favorable safety profile. The company is preparing a Phase III development plan in celiac disease and expects to move the asset from intravenous to subcutaneous administration as quickly as possible.
The company also sees potential for FB-102, which targets CD122, in vitiligo, alopecia and additional autoimmune conditions. Management said it expects to provide a more detailed update on the asset’s broader development strategy in early 2027.
Other pipeline programs include adimanebart, which is advancing to Phase III in congenital myasthenic syndrome, and ARGX-121 in Phase II for IgA nephropathy. argenx expects to have 10 molecules in clinical development by the end of 2026.
Massey reaffirmed the company’s Vision 2030 targets of reaching 50,000 patients, securing 10 labeled indications and having five molecules in Phase III development by the end of the decade. She said MG and CIDP are expected to account for the majority of patient growth, with additional contributions anticipated from IMNM, MMN and other potential approvals.
Management also stressed its use of futility analyses across development programs after discontinuing programs in Sjögren’s syndrome and thyroid eye disease. Massey said the company had not yet reviewed the full Sjögren’s data set but expects the approximately 500 patients who reached week 24 to provide insights for future development decisions. She said the outcome should not be viewed as a read-through to the company’s other rheumatology programs, including its Phase II systemic sclerosis study.
About argenex (NASDAQ:ARGX)
argenx SE NASDAQ: ARGX is a global immunology company focused on developing and commercializing therapies for patients with severe autoimmune diseases. The company uses its antibody engineering capabilities to discover and advance medicines designed to target disease-causing immune mechanisms.
argenx's lead product is VYVGART (efgartigimod alfa), an antibody fragment that targets the neonatal Fc receptor, or FcRn, to reduce levels of disease-causing immunoglobulin G antibodies. VYVGART is approved in several markets for the treatment of generalized myasthenia gravis.
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