Povetacicept (ALPN-303) is a Vertex program in IgA nephropathy. Its PDUFA date is Nov 30, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: IgA nephropathy. Sponsor: Vertex (VRTX). Review status: The FDA accepted the BLA for accelerated approval of povetacicept in IgA nephropathy and assigned a PDUFA target action date of November 30, 2026, per Vertex's own quarterly release; the submission is supported by a pre-specified Week 36 interim analysis of the Phase 3 RAINIER trial. Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Povetacicept (ALPN-303)'s next FDA decision or readout?
Povetacicept (ALPN-303)'s PDUFA date is Nov 30, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Povetacicept (ALPN-303)'s most recent FDA decision?
No FDA decision for Povetacicept (ALPN-303) is in our archive yet.
What is Povetacicept (ALPN-303) used for?
In our records Povetacicept (ALPN-303) is under review or in development for IgA nephropathy.
Who makes Povetacicept (ALPN-303)?
Vertex (VRTX).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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