Orca-T PDUFA Date (Orca Bio)
FDA PDUFA decision date for Orca-T is April 6, 2026. Developed by Orca Bio. Indication: AML, ALL, MDS — high-precision allogeneic cell therapy. Current status: Verifying.
Indication
AML, ALL, MDS — high-precision allogeneic cell therapy
Notes
High-precision allogeneic cell therapy for blood cancers.
Regulatory details
- Company: Orca Bio
- Therapeutic area: Oncology / Cell Therapy
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-04-06
- Outcome: Pending