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Celcuity Announces Promising Phase 3 Trial Results

Story Highlights
  • Celcuity Inc. focuses on developing targeted therapies for advanced breast cancer.
  • The VIKTORIA-1 trial showed significant efficacy of gedatolisib regimens, potentially setting a new treatment standard.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Celcuity Announces Promising Phase 3 Trial Results

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Celcuity ( (CELC) ) has issued an announcement.

On October 18, 2025, Celcuity Inc. announced significant results from their Phase 3 VIKTORIA-1 clinical trial at the ESMO Congress, highlighting the efficacy of gedatolisib regimens in treating HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The trial demonstrated that the gedatolisib triplet and doublet regimens significantly improved median progression-free survival compared to fulvestrant, marking a potential new standard of care for patients whose disease progressed after CDK4/6 inhibitor treatment. The company is advancing a New Drug Application with the FDA based on these findings, aiming for completion by the end of 2025.

The most recent analyst rating on (CELC) stock is a Buy with a $68.00 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, specifically for hormone receptor-positive, HER2-negative advanced breast cancer.

Average Trading Volume: 1,585,596

Technical Sentiment Signal: Buy

Current Market Cap: $2.2B

See more data about CELC stock on TipRanks’ Stock Analysis page.

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