Minneapolis-based Celcuity’s experimental breast cancer therapy gedatolisib demonstrated significant efficacy in a phase III trial, achieving primary endpoints and substantially reducing progression risk in hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer patients. The results position Celcuity for an FDA filing in Q4 2025 and drove shares to surge over 170%. The trial showed benefits in combination regimens with fulvestrant and CDK4/6 inhibitors, with improved progression-free survival and tolerability compared to prior therapies. This breakthrough could challenge existing treatments from Novartis and Roche in this subset.