Celcuity's Supplemental New Drug Application For REVTORPYK Accepted for FDA Review To Treat Hormone Receptor Positive

Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that the U.S. Food and Drug Administration ("FDA") has accepted for review its supplemental New Drug Application ("sNDA") for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. The FDA assigned a Prescription Drug User Fee Act ("PDUFA") goal date of June 25, 2027.