Celcuity Inc. Reports Release of Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

The U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted Priority Review with a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, for gedatolisib in HR+/HER2-/PIK3CA wild-type (“WT”) advanced breast cancer (“ABC”)Results from PIK3CA WT cohort of Phase 3 VIKTORIA-1 study of gedatolisib regimens in HR+/HER2- ABC published in Journal of Clinical OncologyTopline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 study are expected ...