Monday, June 29, 2026
Approved
approved Note: Approved 2026-06-05 as HYMPAVZI (SUPPL BLA761369). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 24d from the PDUFA date.
Drug Information
- Drug Name
- HYMPAVZI (marstacimab) (CT.gov)
- Application Type
- sBLA
- FDA Designations
- Priority ReviewBreakthrough
- Indication
- Hemophilia A or B (pediatric 6-11, and patients with inhibitors)
- Approved As
- HYMPAVZI (marstacimab)
Filing Details
- Company
- Pfizer Inc. →
- Stock Ticker
- PFE
- SEC CIK
- 0000078003
- Source
- Company IR →
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
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue