# HYMPAVZI (marstacimab-hncq) PDUFA Event: Hemophilia A or B in pediatric and inhibitor populations

Canonical URL: https://biopharmsignal.com/pdufa-calendar/PFE/hympavzi-hemophilia-pediatric-and-inhibitor-populations

Ticker: PFE

Company: Pfizer, Inc.

Event date: 2026-06-29

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-06-08

Application type: sBLA

FDA approved two additional HYMPAVZI populations. FDA expanded HYMPAVZI prophylaxis to patients aged 12 years and older with hemophilia A or B and inhibitors...

## Event Timeline

### June 8, 2026 — FDA approved two additional HYMPAVZI populations

FDA expanded HYMPAVZI prophylaxis to patients aged 12 years and older with hemophilia A or B and inhibitors, and to children aged 6 to 11 years with or without inhibitors.

[Pfizer — HYMPAVZI FDA label expansion](https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-hympavzi-treatment-two-additional)

### February 6, 2026 — FDA accepted the sBLA with Priority Review

FDA accepted the application based on Phase 3 BASIS and BASIS KIDS data and granted Priority Review.

[Pfizer — HYMPAVZI sBLA Priority Review](https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-priority-review-hympavzir-marstacimab-sbla)

### June 26, 2025 — Phase 3 BASIS reported positive topline results

HYMPAVZI significantly reduced treated annualized bleeding rates versus on-demand bypassing-agent treatment in adults and adolescents with inhibitors.

[Pfizer — Positive Phase 3 BASIS topline results](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-3-results)

### December 9, 2022 — Phase 3 BASIS KIDS study started

The pediatric trial began evaluating marstacimab in children with hemophilia A or B, with and without inhibitors.

[ClinicalTrials.gov — BASIS KIDS study record (NCT05611801)](https://clinicaltrials.gov/study/NCT05611801)

### March 9, 2020 — Phase 3 BASIS study started

The pivotal study began evaluating marstacimab in adolescents and adults with severe hemophilia A or moderately severe to severe hemophilia B.

[ClinicalTrials.gov — BASIS study record (NCT03938792)](https://clinicaltrials.gov/study/NCT03938792)

## Regulatory Designations

- Priority Review FDA: [Pfizer — HYMPAVZI sBLA acceptance and Priority Review](https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-priority-review-hympavzir-marstacimab-sbla)

## Related Pages

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

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

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

## Related News

- 2003-06-18 — Pfizer sees Strong Prospects Based on Rapid Integration of Pharmacia and Expanded Product and R&D Opportunities: https://biopharmsignal.com/news/PFE/pfizer-sees-strong-prospects-based-on-rapid-integration-of-pharmacia-and-expande-8fbf3352.md