05:38 PM EDT, 08/27/2025 (MT Newswires) -- Celcuity ( CELC ) said late Wednesday the US Food and Drug Administration has agreed to review its new drug application for gedatolisib under the Real-Time Oncology Review program for treating HR+/HER2- advanced breast cancer.

The rolling application submission for the drug candidate is expected in September, with a completion aimed for Q4, the company said.

Celcuity ( CELC ) said its submission is supported by positive topline results from the PIK3CA wild-type group in the phase 3 VIKTORIA-1 trial.