Minneapolis-based Celcuity reported positive topline results from its phase III Viktoria-1 trial evaluating gedatolisib-based combinations for hormone receptor-positive, HER2-negative breast cancer patients with wild-type PIK3CA. The drug combinations significantly reduced the risk of disease progression and death, including a 76% risk reduction with a triplet regimen. The promising outcomes set the stage for a planned FDA approval filing in the fourth quarter. Following the results, Celcuity’s shares soared, more than tripling in value amid investor optimism.