04:25 PM EST, 11/17/2025 (MT Newswires) -- Celcuity ( CELC ) said late Monday it submitted a new drug application to the US Food and Drug Administration for gedatolisib to treat advanced breast cancer.

The NDA was submitted under the regulator's Real-Time Oncology Review program, designed to facilitate shorter review periods, the company said.

The NDA submission was founded on efficacy results for the PIK3CA wild-type cohort of a phase 3 trial. Gedatolisib previously received Breakthrough Therapy and Fast Track designations based on preliminary clinical data, the company said.