Celcuity reported successful Phase 3 trial results for its breast cancer combination therapy gedatolisib, which delayed tumor progression and met primary endpoints in relevant patient populations. This achievement positions the biotech for an impending US FDA filing scheduled for the fourth quarter. The data could challenge established therapies from Novartis and Roche and advance options for certain breast cancer patients. Celcuity’s approach underscores ongoing efforts to enhance targeted cancer treatment efficacy in competitive oncology markets.