Posted by Michael Wonder on 20 Jan 2026
Celcuity announces FDA acceptance of new drug application for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
20 January 2026 - Celcuity today announced that the US FDA has accepted for filing its new drug application for gedatolisib in hormone receptor positive, human epidermal growth factor receptor 2 negative, PIK3CA wild type advanced breast cancer
The FDA granted priority review and assigned a PDUFA goal date of 17 July 2026.
