Minneapolis-based Celcuity reported positive top-line results from its Phase III Viktoria-1 trial evaluating the breast cancer drug gedatolisib. The drug, tested in hormone receptor-positive, HER2-negative patients without PI3KCA mutations who progressed after prior therapy, demonstrated a significant improvement in progression-free survival when combined with fulvestrant and other agents. The trial success positions Celcuity for a planned FDA New Drug Application submission later this year. Celcuity's shares soared over 160% on the news, reflecting investor enthusiasm over the potentially practice-changing treatment option for a difficult breast cancer subset.