Bitopertin PDUFA Date (Disc Medicine)
FDA PDUFA decision date for Bitopertin is February 13, 2026. Developed by Disc Medicine. Indication: Erythropoietic protoporphyria (EPP). Current status: CRL.
Indication
Erythropoietic protoporphyria (EPP)
Regulatory details
- Company: Disc Medicine
- Therapeutic area: Rare Disease / Hematology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-02-13
- Outcome: CRL