# Povetacicept (ALPN-303) PDUFA Event: Immunoglobulin A nephropathy

Canonical URL: https://biopharmsignal.com/pdufa-calendar/VRTX/povetacicept-iga-nephropathy

Ticker: VRTX

Company: Vertex Pharmaceuticals Incorporated

Event date: 2026-11-30

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

FDA decision expected. FDA assigned a November 30, 2026 PDUFA target action date to the BLA seeking accelerated approval of povetacicept.

## Event Timeline

### November 30, 2026 — FDA decision expected

FDA assigned a November 30, 2026 PDUFA target action date to the BLA seeking accelerated approval of povetacicept.

[Vertex — BLA acceptance and PDUFA date](https://news.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application)

### June 1, 2026 — FDA accepted the BLA

FDA accepted the application for adults with IgA nephropathy. Vertex used a Priority Review Voucher to shorten the review timeline.

[Vertex — BLA acceptance](https://news.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application)

### March 31, 2026 — Vertex completed the rolling BLA submission

Vertex completed the application seeking accelerated approval after positive interim data from the Phase 3 RAINIER trial.

[Vertex — Completed rolling BLA submission](https://news.vrtx.com/static-files/2ec1b2a3-a293-47be-97c6-7eab0f95fadc)

### March 9, 2026 — RAINIER met its interim-analysis objectives

Povetacicept produced a 49.8% reduction in proteinuria versus placebo at Week 36 and met both alpha-controlled secondary endpoints.

[Vertex — Positive Phase 3 RAINIER interim results](https://news.vrtx.com/news-releases/news-release-details/vertex-announces-positive-week-36-interim-analysis-results)

### September 25, 2025 — FDA granted Breakthrough Therapy designation

FDA granted Breakthrough Therapy designation to povetacicept for IgA nephropathy.

[Vertex — Breakthrough Therapy designation](https://news.vrtx.com/news-releases/news-release-details/vertex-announces-key-advancements-across-kidney-portfolio)

### August 30, 2024 — Phase 3 RAINIER study started

The pivotal study began evaluating povetacicept in adults with IgA nephropathy and later generated the interim proteinuria and remission dataset supporting the BLA.

[ClinicalTrials.gov — RAINIER study record (NCT06564142)](https://clinicaltrials.gov/study/NCT06564142)

## Regulatory Designations

- Breakthrough Therapy FDA: [Vertex — Breakthrough Therapy designation in IgA nephropathy](https://news.vrtx.com/news-releases/news-release-details/vertex-announces-key-advancements-across-kidney-portfolio)

## Related Pages

- VRTX PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/VRTX.md

- VRTX company profile: https://biopharmsignal.com/company/VRTX.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md