Celcuity reported positive phase III results for its breast cancer drug gedatolisib, significantly reducing progression risk in hormone receptor-positive, HER2-negative advanced tumors that were resistant to prior treatments. The study demonstrated marked progression-free survival benefits in both doublet and triplet drug combinations with FDA submission expected in the fourth quarter. The news caused Celcuity's shares to triple, highlighting enthusiasm for the therapy's potential to challenge existing breast cancer treatments from major pharmaceutical companies.