Celcuity reported phase 3 results for gedatolisib, a pan-PI3K/mTOR inhibitor, in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, saying the trial cleared its primary endpoint. The company said it can now pursue a second regulatory submission for the drug that is already under FDA review, and it also flagged progress in a PIK3CA-mutant cohort.