Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Celcuity said on Aug. 26, 2026 that it submitted the sNDA to the FDA for REVTORPYK, also known as gedatolisib. The proposed use covers patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer carrying a PIK3CA mutation after progression on or after prior treatment.

The named company is Celcuity Inc. (Nasdaq: CELC), and the regulatory mechanism is a supplemental application for an existing product rather than a new molecular entity filing. The announcement does not provide an FDA acceptance decision, a review classification, a target action date, efficacy figures, safety data, or commercial expectations.

The next concrete developments are FDA validation or acceptance of the submission, any assigned review timeline, and subsequent regulatory communications. The release also leaves open how the application’s clinical package will be assessed and whether the proposed indication ultimately receives approval.