Minneapolis-based Celcuity announced positive top-line data from its phase III Viktoria-1 study evaluating gedatolisib in combination with standard treatments for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The investigational drug demonstrated a significant progression-free survival benefit in both two- and three-drug regimens, reducing disease progression or death risk by up to 76%. The promising results position the company for an FDA approval submission later this year, resulting in a sharp increase in Celcuity’s stock price and valuation near $1.5 billion.