Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA 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
MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), advanced breast cancer (“ABC”). 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-type cohort of the Phase 3 VIKTORIA-1 clinical trial. “This NDA submission is an important milestone, and it brings gedatolisib one step closer to becoming available for patients with HR+/HER2- advan
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CELC
News
- Celcuity (NASDAQ:CELC) had its price target raised by analysts at Jefferies Financial Group Inc. from $108.00 to $134.00. They now have a "buy" rating on the stock.MarketBeat
- Celcuity (CELC): Assessing Valuation Following Recent Share Price Surge [Yahoo! Finance]Yahoo! Finance
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- This Fund Bought $38 Million of Celcuity as Stock Surges on Investigational Cancer Drug Results [Yahoo! Finance]Yahoo! Finance
- Celcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium [Yahoo! Finance]Yahoo! Finance
CELC
Earnings
- 11/12/25 - Beat
CELC
Sec Filings
- 12/3/25 - Form 4
- 12/1/25 - Form 144
- 11/24/25 - Form 4
- CELC's page on the SEC website