Celcuity's NDA For Gedatolisib In HR+/HER2- Breast Cancer Accepted Into FDA's Real-Time Oncology Review Program

Author: Benzinga Newsdesk | August 27, 2025 04:14pm

Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the U.S. Food and Drug Administration ("FDA") agreed to accept its New Drug Application ("NDA") for gedatolisib in HR+/HER2- advanced breast cancer ("ABC") for review under the Real-Time Oncology Review ("RTOR") program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA's evaluation of the application. Celcuity is expected to initiate in September a rolling submission to the FDA of its NDA for gedatolisib, based on topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Completion of the NDA submission is targeted for the fourth quarter of 2025.

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