Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Jun 3
- 2 min read
02/06/2026
Gilead announced positive phase 3 results for Seladelpar in PBC (Ref)
Gilead Sciences announced positive results from the Phase 3, IDEAL/ NCT06060665 trial, which showed that Livdelzi® (seladelpar; PPAR‑delta agonist) led to significantly more patients achieving normalization of alkaline phosphatase compared with placebo after 52 weeks.
The safety profile of seladelpar observed in IDEAL was consistent with previously reported Livdelzi studies, with no new safety concerns identified.
Full data will be presented at an upcoming medical congress.
Vera Therapeutics announced US FDA alignment on an earlier ORIGIN phase 3 eGFR analysis to support potential full approval for atacicept in adults with IgA Nephropathy (Ref)
Vera Therapeutics announced it had aligned with the US FDA on a revised, earlier ORIGIN 3 eGFR analysis plan to support full approval for atacicept in adults with IgAN.
The alignment followed a National Kidney Foundation workshop and was supported by eGFR results from the ORIGIN Phase 2b trial.
The revised ORIGIN 3 eGFR analysis was planned for Q3 2026, pulled forward from 2027.
Pending a positive eGFR analysis, the company planned to submit a supplemental Biologics License Application (sBLA) in Q4 2026, with potential full approval in 2027.
A Prescription Drug User Fee Act (PDUFA) date of July 7, 2026 was set for the Biologics License Application for accelerated approval of atacicept in patients with IgA Nephropathy (IgAN).
Rise Therapeutics announced completion of enrollment in the 4-Week dose expansion cohort for R-2487 in RA clinical trial (Ref)
Rise Therapeutics announced the completion of full enrollment in the 4-week dose expansion cohort of its Phase 1b/ NCT05961592 trial, evaluating orally dosed R-2487 in patients with active rheumatoid arthritis (RA).
Data from the 4-week dose expansion cohort would be presented at upcoming national and international rheumatology and immunology conferences.
