Loargys (pegzilarginase) PDUFA Date (Immedica Pharma)
FDA PDUFA decision date for Loargys (pegzilarginase) is February 23, 2026. Developed by Immedica Pharma. Indication: Arginase 1 deficiency (ARG1-D). Current status: Approved.
Indication
Arginase 1 deficiency (ARG1-D)
Regulatory details
- Company: Immedica Pharma
- Therapeutic area: Rare Disease / Metabolic
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-02-23
- Outcome: Approved