07:55 AM EDT, 07/28/2025 (MT Newswires) -- Celcuity ( CELC ) said Monday a phase 3 trial of its drug gedatolisib, combined with fulvestrant, with and without palbociclib, demonstrated a "statistically significant and clinically meaningful" improvement in progression-free survival in a type of breast cancer.

Celcuity ( CELC ) shares rose by more than 112% in premarket trading.

In the trial, the company said the gedatolisib with fulvestrant and palbociclib reduced the risk of disease progression or death by 76% and extended median progression-free survival to 9.3 months, compared with 2 months with fulvestrant alone.

Celcuity ( CELC ) said it plans to file a marketing application for gedatolisib with the US Food and Drug Administration in Q4, with additional data expected by year-end.