Gedatolisib PDUFA Date (Celcuity)
FDA PDUFA decision date for Gedatolisib is July 17, 2026. Developed by Celcuity. Indication: HR+/HER2- PIK3CA wildtype advanced breast cancer. Current status: Approved.
Indication
HR+/HER2- PIK3CA wildtype advanced breast cancer
Notes
Pan-PI3K/mTOR inhibitor. Addresses unmet need in PIK3CA wildtype patients.
Regulatory details
- Company: Celcuity
- Therapeutic area: Oncology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-07-17
- Outcome: Approved