Celcuity reported strong phase III clinical results for gedatolisib in combination therapies targeting hormone receptor-positive, HER2-negative breast cancer lacking PI3KCA mutations. The therapy significantly improved progression-free survival, with triplet regimen reducing risk by 76%, and doublet by 67%. Safety profiles were favorable relative to existing treatments. The data positions Celcuity to file for FDA approval by year’s end and sparked a meteoric rise in its stock price, boosting the company’s market valuation to approximately $1.5 billion.