Minneapolis biotech Celcuity reported positive phase III results for its breast cancer therapy gedatolisib, which demonstrated significant progression-free survival benefits in hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The trial showed disease progression risk reductions of up to 76% with combination regimens, setting the stage for an FDA approval application later this year. Investor response was positive, with shares surging over 170%. The drug’s broad PI3K pathway blockade is positioned to challenge therapies from major pharmaceutical competitors in this space.