Minneapolis-based biotech Celcuity announced positive top-line Phase III trial results for gedatolisib in combination therapies for hormone receptor-positive, HER2-negative advanced breast cancer. The trial showed significant progression-free survival benefits and reduced risk of disease progression compared to standard treatments. These results position Celcuity for a planned FDA submission later this year. The stock price surged more than threefold on the news, boosting market valuation to approximately $1.5 billion.