Celcuity reported positive results from its Phase III Viktoria-1 trial evaluating gedatolisib in hormone receptor-positive, HER2-negative breast cancer patients. The trial demonstrated significant progression-free survival benefits with both doublet and triplet drug combinations, showing potential to change treatment standards. With reduced adverse event discontinuations compared to previous therapies, Celcuity plans to file for FDA approval in the fourth quarter. The company’s stock price surged dramatically following the data release, boosting its market capitalization above $1.5 billion.