Povetacicept (ALPN-303)
FDA PDUFA Target Action Date · Vertex Pharmaceuticals Incorporated
Note: FDA accepted the BLA for accelerated approval; PDUFA target action date Nov 30, 2026 (announced 2026-06-01). Povetacicept is an engineered dual BAFF/APRIL inhibitor; supported by the prespecified Week-36 interim of the Phase 3 RAINIER trial. Holds FDA Breakthrough Therapy Designation for IgAN; ~6-month review window is consistent with priority handling. Would be the first commercialized product in Vertex's nephrology franchise.
Drug Information
- Drug Name
- Povetacicept (ALPN-303) (CT.gov)
- Application Type
- BLA
- FDA Designations
- Breakthrough Therapy
- Indication
- IgA nephropathy (IgAN) in adults (accelerated approval pathway)
Filing Details
- Company
- Vertex Pharmaceuticals Incorporated
- Stock Ticker
- VRTX
- SEC CIK
- Source
- company-press-release →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue