Celcuity won U.S. FDA approval for Revtorpyk (gedatolisib), the company’s first commercial product, clearing a new therapeutic entry in hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. The approval covers patients without a PIK3CA mutation and who have progressed after at least one line of endocrine therapy in the metastatic setting. While approval broadens Celcuity’s path toward commercialization, investors reacted to disclosures about timing—particularly a delayed launch expected late in the third quarter of 2026. The company also highlighted continued development with plans to expand into additional indications. The decision underscores continued interest in pathway inhibition for HR+/HER2− disease subsets where targeted options remain limited, and it positions Celcuity as a new branded player rather than a clinical-stage biotech. For clinicians, Revtorpyk’s specific biomarker requirement is likely to shape uptake, given existing PI3K-pathway competitors and the need to align testing workflows with prescribing.