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

Core Insights - Celcuity Inc. (NASDAQ:CELC) is gaining attention as a leading SMID-cap stock in 2025, with Wolfe Research initiating coverage on November 17, giving it an Outperform rating and a price target of $110 [1][2]. Clinical Progress - The company has shown strong momentum following the successful Phase 3 trial of gedatolisib for second-line PIK3CA-WT breast cancer, which is expected to be a key catalyst with the upcoming PIK3CA-mt readout in 2026 [2]. - Celcuity submitted its New Drug Application (NDA) for gedatolisib to the U.S. FDA on the same day as the coverage initiation [3]. Trial Results - Detailed results from the Phase 3 VIKTORIA-1 clinical trial presented at the ESMO Congress indicated a significant efficacy of gedatolisib, showing up to a 76% reduction in the risk of disease progression or death in the PIK3CA WT cohort [4]. Strategic Positioning - The continued clinical advancements have enhanced Celcuity's strategic value, making it an attractive acquisition target for larger pharmaceutical companies [2].