Celcuity Inc. announced the FDA approval of REVTORPYK (gedatolisib) for treating HR+/HER2- locally advanced or metastatic breast cancer in patients without a PIK3CA mutation. The company anticipates a commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application (sNDA) in Q3 2026 for the PIK3CA mutated cohort. Celcuity Inc. is a biopharmaceutical company focused on developing precision medicine therapies for cancer.
