Novel gedatolisib is currently under review at FDA for wild-type patients

Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.

Celcuity's gedatolisib doubled progression-free survival versus Novartis' Piqray in late-stage breast cancer, setting up a third-quarter FDA submission.