Argenx SE (ARGX), a commercial-stage immunology company, reported first-quarter results reflecting 63% revenue growth and provided updates on the near-term milestones for the lead product candidates and development pipeline.
Company Profile
Argenx SE develops therapies for the treatment of autoimmune diseases. The firm's lead product candidate, VYVGART or Efgartigimod, is approved in three indications, including generalised myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan.
Argenx is also developing Empasiprubart, a humanised monoclonal antibody being evaluated in registrational studies in multifocal motor neuropathy (MMN) and CIDP, and in a combination study with VYVGART in gMG.
First Quarter Results
For the first quarter of 2026, profit for the period increased to $366 million from $169 million in the prior year.
On a per-share basis, net income increased to $5.53 from $2.58 in the prior year.
Product net sales increased to $1.29 billion from $0.790 billion in the prior year.
As of March 31, 2026, the cash, cash equivalents and current financial assets of the firm totalled $4.9 billion.
Near-Term Milestones
VYVGART or Efgartigimod -Prescription Drug User Fee Act (PDUFA) target action date for a supplemental approval seeking to expand VYVGART's use for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalised myasthenia gravis (gMG) is on May 10, 2026.
-Topline results from the ALKIVIA Phase 2/3 study evaluating subcutaneous Efgartigimod in patients with idiopathic inflammatory myopathy (myositis) are expected in the third quarter of 2026.
-Topline results from the UNITY Phase 3 study evaluating Efgartigimod in Sjogren's disease are expected in the second half of 2027.
-In addition, the VYVGART SC autoinjector is expected to launch in 2027 for all approved indications.
-Positive topline results presented at AAN from ADAPT OCULUS support planned sBLA submission to expand VYVGART label into Ocular myasthenia gravis.
Empasiprubart
-Topline results from the EMPASSION study evaluating Empasiprubart in Multifocal motor neuropathy or (MMN) are expected in the fourth quarter of 2026.
-Topline results from EMVIGORATE and EMNERGIZE studies (CIDP) of Empasiprubart are expected in the second half of 2027.
-Decision for Phase 2 VARVARA study of Empasiprubart in Delayed Graft Function is expected mid-year 2026, following completion of 52-week efficacy analysis.
In addition,Argenx expects to include ten molecules in clinical development by the end of 2026.Beyond Efgartigimod and Empasiprubart, this includes Adimanebart, a MuSK-targeting agonist antibody; ARGX-121 (anti-IgA), ARGX-109 (anti-IL-6), and three additional molecules from the Immunology Innovation Program (IIP).
-For Adimanebart, the firm noted that the CMS registrational study is on track to start in the third quarter of 2026.
-For ARGX-121, the Phase 2 study in IgA nephropathy (IgAN) is expected to start in 2026.
-ARGX-118, a Galectin-10 inhibitor; ARGX-125, a bispecific antibody; and TSP-101, the Fn14-targeting program from the Tensegrity research collaboration, are on track to enter Phase 1 studies in 2026, according to the firm.
ARGX has traded between $510.05 and $934.62 over the last year. The stock closed Wednesday's trade at $807.55, up 1.62%.
In the pre-market, ARGX is up 2.39% at $826.83.
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