Celcuity (CELC)'s Clinical Success and M&A Potential Underpin Wolfe Research's Bullish View

Celcuity Inc. (NASDAQ:CELC) is among the hottest SMID-cap stocks so far in 2025. Following recent clinical progress, Wolfe Research initiated coverage on Celcuity on November 17, with an Outperform rating and a $110 price target, according to TheFly.

The firm highlighted the company’s strong momentum following the recent Phase 3 success for gedatolisib in second-line PIK3CA-WT breast cancer. With that success, it believes that the upcoming PIK3CA-mt readout should be a key catalyst in 2026. In addition, Wolfe Research believes that continued clinical progress has strengthened the company’s strategic value, positioning Celcuity as a compelling acquisition target for large pharmaceutical companies.

On the same day, November 17, the company announced that it had submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib.

Earlier, on October 18, the company had announced detailed efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib at the European Society for Medical Oncology (ESMO) Congress. The data indicated a significant improvement through the therapy, with up to a 76% reduction in the risk of disease progression or death.

Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology company pursuing the development of targeted therapies for oncology.

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Disclosure: None. This article is originally published at Insider Monkey.