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 [Yahoo! Finance]
Celcuity Inc. (CELC)
Last celcuity inc. earnings: 3/12 04:00 pm
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Source: Yahoo! Finance
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- advanced breast cancer,” said Brian Sullivan, CEO and co-founder of Celcuity. “We look forward to working with the
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News
- 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
- Celcuity (CELC): Fresh Phase 3 Breast Cancer Data Prompts Closer Look at Gedatolisib-Driven Valuation [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