Argenx advances FB102 to Phase 3 after celiac win, but Vyvgart Sjögren’s failure hits stock
Argenx reported that its anti-CD122 antibody FB102 met its primary endpoint in a Phase 2 celiac disease trial, supporting a move to Phase 3. Simultaneously, the company announced that its blockbuster drug Vyvgart failed a Phase 3 trial for Sjögren’s disease, causing shares to drop 13%.
Key points
- FB102 showed statistically significant improvement in villus height-to-crypt depth (Vh:Cd) at Day 78 in 126 adults with celiac disease.
- Argenx plans to advance FB102 into Phase 3 development, targeting the IL-15 signaling pathway.
- The company acquired FB102 from Forte Biosciences in a $2.2 billion deal finalized in July 2026.
- Vyvgart failed to outperform placebo in a Phase 3 trial for Sjögren’s disease, leading to an early termination of the study.
- Argenx stock fell 13% following the announcement of the Vyvgart setback.
Background
In September 2026, Teva’s rival anti-IL-15 antibody TEV-408 also achieved success in a Phase 2a celiac trial, intensifying competition in the autoimmune space. Argenx had previously acquired Forte Biosciences to secure FB102, which had already shown promise in vitiligo trials.
How outlets are covering it
Fierce Biotech highlights the strategic importance of FB102 in diversifying Argenx’s portfolio away from Vyvgart, noting that TD Cowen analysts predict a 2031 launch for FB102. STAT emphasizes the severity of the Vyvgart failure as an 'unusual setback' for a company with a strong track record in autoimmune disorders. Yahoo Finance reported on the immediate market reaction, noting the 13% stock plunge, though its detailed analysis was obscured by technical errors in the source text.
Why it matters
The outcome determines Argenx’s ability to reduce reliance on its flagship drug and positions it against Teva in a potentially blockbuster celiac market. The Vyvgart failure threatens revenue stability, making the success of new candidates like FB102 critical for the company’s future growth.
What to watch
Argenx will initiate Phase 3 trials for FB102 in celiac disease. Teva is expected to run another Phase 2 trial before entering pivotal development. Investors will monitor Argenx’s pipeline for other indications, including vitiligo and alopecia, to offset the loss of the Sjögren’s opportunity.
- Argenx digests phase 2 celiac win for $2.2B drug, preps pivotal run Fierce Biotech
- Argenx sees unusual setback with failure of late-stage study of drug for autoimmune disease STAT
- Why Is ARGX Stock Plunging Today? Yahoo Finance
- Argenx discontinues Vyvgart study in Sjögren's disease, shares tumble Reuters
- Former Highflying Biotech Hits The Skids On A Surprise Failure Investor's Business Daily
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