NasdaqCM:CELCBiotechs
Celcuity (CELC) Is Up 11.3% After FDA Grants Priority Review To Gedatolisib NDA - What's Changed
Celcuity Inc. recently announced that the FDA accepted for filing its New Drug Application for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
This filing advances a differentiated, multi-target PAM pathway inhibitor that has already received Breakthrough Therapy and Fast Track designations, highlighting its potential clinical relevance versus single-target therapies.
Next, we’ll examine how the FDA’s...