Celcuity said its investigational therapy gedatolisib met both progression-free survival primary endpoints in the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 study in hormone receptor-positive, HER2-negative metastatic breast cancer. The triplet regimen of gedatolisib, palbociclib and fulvestrant cut the risk of disease progression or death by 76% versus fulvestrant alone, delivering a median PFS of 9.3 months compared with 2.0 months for the control. A doublet of gedatolisib and fulvestrant reduced the risk by 67% and produced a median PFS of 7.4 months. According to the company, the hazard ratios of 0.24 and 0.33 are the most favorable reported in a Phase 3 trial for this patient population, which typically derives limited benefit after CDK4/6 inhibitor failure. Investigators said the data suggest gedatolisib could become the first PI3K/AKT/mTOR pathway inhibitor to show robust efficacy in patients whose tumors lack PIK3CA mutations. Celcuity reported a lower treatment-related discontinuation rate than seen in earlier studies and in other approved combinations, pointing to a manageable safety profile with fewer cases of hyperglycemia and stomatitis. The Minneapolis-based company plans to submit a U.S. New Drug Application for gedatolisib in the fourth quarter of 2025 and will present full trial data later this year. Top-line results from the PIK3CA-mutant arm are expected by year-end 2025. Celcuity’s shares surged more than 200% in early trading following the announcement.