Argenx halts Sjögren’s disease Phase 3 trial while reporting positive Phase 2 celiac results
Argenx announced that its Phase 3 UNITY study of efgartigimod for Sjögren’s disease was stopped after an independent data monitoring committee deemed the trial futile. On the same day the company released topline data from a Phase 2 study of its CD122 inhibitor FB102 in celiac disease, which met its primary biopsy endpoint. The celiac trial enrolled 126 patients and showed a statistically significant improvement in villus height‑to‑crypt depth ratio (p = 0.0176).
Why it matters
The company said the positive Phase 2 data support advancing FB102 into Phase 3 development, offering a potential first‑in‑class therapy for a disease with no approved drugs. However, analysts note that the halted Sjögren’s trial removes a projected $1.4 billion revenue opportunity, and the stock fell more than 15% on the news.
Key facts
- 1The Phase 2 FB102 study met its primary endpoint of change from baseline in the villus height‑to‑crypt depth ratio at day 78 (p = 0.0176). globenewswire.com
- 2The FB102 trial enrolled 126 adult patients with celiac disease. globenewswire.com
- 3Argenx will advance FB102 into Phase 3 development. globenewswire.com
- 4The Phase 3 UNITY trial of efgartigimod for Sjögren’s disease was halted for futility after an IDMC recommendation. globenewswire.com
- 5Argenx shares fell 7.91% overnight following the announcement. rttnews.com
- 6Argenx reported US$1.5 billion in second‑quarter product sales and US$472 million profit. mugglehead.com
Summary written by AlphAI from 20 of 22 sources. Not investment advice. Figures are as stated by the linked sources.