Celcuity announced positive top-line results from a Phase 3 trial evaluating its experimental breast cancer drug gedatolisib in combination with standard therapies for hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The treatment significantly reduced progression risk and extended progression-free survival, surpassing study endpoints. The company plans an FDA approval submission this year. Celcuity's share price surged over 160% on the news, valuing the company at roughly $1.5 billion, reflecting strong investor enthusiasm for the potential new treatment option.