Chase Knickerbocker

Gil Blum

Maurice Raycroft

Bradley Canino

Oliver McCammon

Tara Bancroft

Amin Makarem

Andrew Berens

Eason Lee

Frances Dovell

Frances Duvall

Stephen Willey

- **Celcuity Inc.** announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for **gedatolisib** in HR+/HER2- advanced breast cancer (ABC) for review under the **Real-Time Oncology Review (RTOR) program**.  **[1603454_7390a4fd03cf45d9940f47061b37d5d4_0]** 
- Celcuity plans to initiate a rolling submission of its NDA for gedatolisib in **September**, with the full submission targeted for completion in the **fourth quarter of 2025**.  **[1603454_7390a4fd03cf45d9940f47061b37d5d4_0]** 
- The NDA submission is based on positive topline results from the _PIK3CA_ wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial, where the gedatolisib-triplet reduced the risk of disease progression or death by **76%** (hazard ratio of **0.24**) and achieved a median progression-free survival of **9.3 months**.  **[1603454_7390a4fd03cf45d9940f47061b37d5d4_0]**

Celcuity's NDA for Gedatolisib Accepted for FDA Real-Time Oncology Review

Celcuity (CELC)