Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Jun 2
- 1 min read
01/06/2026
Vertex announced US FDA acceptance of BLA for accelerated approval of Povetacicept in IgA nephropathy (Ref)
Vertex Pharmaceuticals announced that the US FDA had accepted its Biologics License Application (BLA) submission for povetacicept (anti-BAFF and APRIL) in adults with immunoglobulin A nephropathy (IgAN).
The submission was supported by positive data from a pre-specified Week 36 interim analysis of the Phase 3 RAINIER trial of povetacicept in IgAN.
Povetacicept was generally safe and well tolerated.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026.
Abivax announced Phase 3 maintenance results for obefazimod in moderately to severely active UC (Ref)
Abivax announced positive topline results from the Phase 3, ABTECT maintenance trial which evaluated obefazimod (miR-124 enhancer) in adults with moderately to severely active ulcerative colitis (UC).
At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p<0.0001).
Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial, with no new safety signals.
The Company planned to submit a New Drug Application (NDA) to the US FDA for obefazimod in UC in late Q4 2026.
