Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
Celcuity Inc. (CELC)
Last celcuity inc. earnings: 3/12 04:00 pm
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Source: GlobeNewswire
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced breast cancer (“ABC”). The FDA granted Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026. The NDA was submitted under the FDA’s Real-Time Oncology Review (“RTOR”) program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data. The submission is based on clinical data from the PIK3CA wild-t
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News
- Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer [Yahoo! Finance]Yahoo! Finance
- Wells Fargo Initiates Coverage On Celcuity Inc. (CELC) [Yahoo! Finance]Yahoo! Finance
- Celcuity (CELC) Surges 662% in 2025 on Breast Cancer Treatment Trial Results [Yahoo! Finance]Yahoo! Finance
- Celcuity: After Stellar 2025, I Predict More Success In 2026 And Beyond [Seeking Alpha]Seeking Alpha
- How Investors Are Reacting To Celcuity (CELC) Gedatolisib's Phase 3 Breast Cancer Data And Safety Profile [Yahoo! Finance]Yahoo! Finance
CELC
Earnings
- 11/12/25 - Beat
CELC
Sec Filings
- 1/16/26 - Form SCHEDULE
- 1/9/26 - Form 4
- 1/9/26 - Form S-3ASR
- CELC's page on the SEC website