Celcuity Announces Positive Phase 3 Trial Results

Celcuity ( (CELC) ) has shared an announcement.

On July 28, 2025, Celcuity Inc. announced positive topline results from its Phase 3 VIKTORIA-1 clinical trial, which evaluated gedatolisib plus fulvestrant with and without palbociclib in patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The trial demonstrated significant improvements in progression-free survival, with the gedatolisib triplet reducing the risk of disease progression or death by 76% and the gedatolisib doublet by 67% compared to fulvestrant alone. These results mark unprecedented milestones in drug development for this type of cancer, with gedatolisib showing a favorable safety profile and potential to become a transformative treatment option.

The most recent analyst rating on (CELC) stock is a Buy with a $29.00 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.

Average Trading Volume: 208,438

Technical Sentiment Signal: Buy

Current Market Cap: $521.4M

For a thorough assessment of CELC stock, go to TipRanks’ Stock Analysis page.