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An update from Celcuity ( (CELC) ) is now available.
On November 17, 2025, Celcuity Inc. announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration for gedatolisib, targeting hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer. This submission, under the FDA’s Real-Time Oncology Review program, is based on promising Phase 3 VIKTORIA-1 trial results, showing significant efficacy in reducing disease progression risk. The NDA marks a significant milestone for Celcuity, potentially altering treatment practices for HR+/HER2- advanced breast cancer patients.
The most recent analyst rating on (CELC) stock is a Hold with a $94.00 price target. To see the full list of analyst forecasts on Celcuity stock, see the CELC Stock Forecast page.
Spark’s Take on CELC Stock
According to Spark, TipRanks’ AI Analyst, CELC is a Neutral.
Celcuity’s stock score of 43.73 reflects the challenges faced by early-stage biotech firms. The company’s financial performance is weak due to lack of revenue and high expenses. Technical analysis shows a neutral to slightly negative outlook, while valuation metrics are poor due to negative earnings. Despite these challenges, the earnings call provided a positive outlook with potential future revenue and strong financial positioning. The overall score indicates significant risks but potential for future growth if clinical and financial milestones are achieved.
To see Spark’s full report on CELC stock, click here.
More about Celcuity
Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, particularly for multiple solid tumor indications. Its lead therapeutic candidate, gedatolisib, is a potent, pan-PI3K and mTORC1/2 inhibitor designed to comprehensively block the PAM pathway, differentiating it from other therapies targeting PI3Kα, AKT, or mTORC1.
Average Trading Volume: 1,097,505
Technical Sentiment Signal: Buy
Current Market Cap: $4.29B
See more insights into CELC stock on TipRanks’ Stock Analysis page.

