Celcuity Reports Q4 and FY2025 Financial Results, FDA Grants Priority Review for Gedatolisib in HR+/HER2- Advanced Breast Cancer.

Celcuity Inc. reported its Q4 and full-year 2025 financial results and provided a corporate update. The FDA accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer and granted Priority Review with a PDUFA goal date of July 17, 2026. The Phase 3 VIKTORIA-1 study results were published in the Journal of Clinical Oncology, and topline results from the PIK3CA mutant cohort are expected in Q2 2026. The company plans to launch gedatolisib commercially in Q3 2026, pending FDA approval.