Vera Therapeutics Announces Alignment with U.S. FDA on Earlier ORIGIN Phase 3 Analysis to Support Potential Full Approval for Atacicept in Adults with IgA Nephropathy
Vera Therapeutics has aligned with the FDA on an accelerated development plan for its lead asset atacicept in IgA Nephropathy (IgAN). The pivotal ORIGIN Phase 3 eGFR analysis has been pulled forward from 2027 to Q3 2026, supporting a supplemental BLA submission in Q4 2026 and a PDUFA date for accelerated approval on July 7, 2026.
Key figures
- Drug Name
- atacicept
- Phase Of Trial
- Phase 3
- Pdufa date
- July 7, 2026
- Patients treated
- 1,500
- Egfr analysis date
- Q3 2026
- Full approval target
- 2027
- Sbla submission date
- Q4 2026
AI analysis
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