The FDA approved Celcuity’s Revtorpyk (gedatolisib), marking the company’s first U.S. commercialization and its entry into a pathway inhibitor class aimed at PAM signaling. The approval covers patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without PIK3CA mutations after progression on or following endocrine therapy, with investor focus also on a reported launch timing delay.