Celcuity Submits New Drug Application to FDA for Gedatolisib in Advanced Breast Cancer

Reuters11-18

Celcuity Submits New Drug Application to FDA for Gedatolisib in Advanced Breast Cancer

Celcuity Inc. has announced the completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for gedatolisib, a treatment for hormone receptor positive (HR+), HER2-negative, PIK3CA wild-type advanced breast cancer. The NDA was submitted under the FDA's Real-Time Oncology Review (RTOR) program, which aims to expedite the review process. Gedatolisib previously received Breakthrough Therapy and Fast Track designations based on promising clinical data from the Phase 3 VIKTORIA-1 trial. The application is currently under regulatory review; no final approval has been granted yet. There is no indication that this submission involves funding or participation from organizations other than Celcuity Inc.

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: GNW9577340-en) on November 17, 2025, and is solely responsible for the information contained therein.

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The NDA was submitted under the FDA's Real-Time Oncology Review (RTOR) program, which aims to expedite the review process. Gedatolisib previously received Breakthrough Therapy and Fast Track designations based on promising clinical data from the Phase 3 VIKTORIA-1 trial. The application is currently under regulatory review; no final approval has been granted yet. There is no indication that this submission involves funding or participation from organizations other than Celcuity Inc.\n      \n\nDisclaimer: 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. 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