FDA Accepts Celcuity New Drug Application for Gedatolisib in Advanced Breast Cancer

Reuters01-20

FDA Accepts Celcuity New Drug Application for Gedatolisib in Advanced Breast Cancer

Celcuity Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for gedatolisib, a multi-target PI3K/AKT/mTOR inhibitor, for the treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA wild-type advanced breast cancer. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026. The NDA submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Gedatolisib has previously received Breakthrough Therapy and Fast Track designations.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9628306-en) on January 20, 2026, and is solely responsible for the information contained therein.

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