Perceptive Advisors purchased 203,881 shares of Celcuity (CELC) in Q4 2025 for approximately $16.76 million, bringing its stake to 5.62% of AUM and making it the fund's second-largest holding. The stock has surged 700% over the past year, driven by anticipation of FDA approval for the company's lead drug candidate Gedatolisib, which has a PDUFA goal date of July 17, 2026. The significant investment by a specialist biotech investor suggests conviction that major catalysts remain ahead.

Soleus Capital Management increased its stake in Celcuity by 629,398 shares, bringing its total holdings to over 1.8 million shares valued at $180.36 million. This purchase elevated Celcuity to Soleus's third-largest holding, representing 6.7% of the fund's AUM. The move signals bullish confidence in the clinical-stage biotech company, which has seen its stock surge 745% over the past year.

Celcuity director David Dalvey sold 20,000 shares indirectly for $2.4 million on January 27, 2026, representing 18.18% of his holdings. The sale occurred via a Rule 10b5-1 trading plan through Brightstone Venture Capital Fund. Despite the insider sale, Celcuity stock has surged 933% over the past year following positive clinical trial results for its breast cancer treatment, though the company remains unprofitable.

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Apis Capital Advisors invested $38.3 million in Celcuity, acquiring 776,000 shares during Q3 2025, making it their largest holding. Celcuity, a clinical-stage biotech firm, has seen its stock surge 669% in a year following positive phase 3 results for its cancer drug gedatolisib.

Celcuity announced promising Phase 3 trial results for gedatolisib, a multi-target PAM inhibitor for advanced breast cancer, demonstrating significant improvements in progression-free survival and response rates compared to standard treatment.

Celcuity reported promising Phase 1 clinical trial results for gedatolisib combined with darolutamide in metastatic castration-resistant prostate cancer, showing a 67% six-month progression-free survival rate and generally well-tolerated treatment.

Celcuity announced full enrollment of the PIK3CA mutant cohort in its Phase 3 VIKTORIA-1 clinical trial, with expected topline data in late Q1 or Q2 2026. Preliminary Phase 1b data showed promising median progression-free survival of 14.6 months for patients with PIK3CA-mutated advanced breast cancer.

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The article discusses recent advancements in cancer research and treatment, including promising results from clinical trials of various cancer therapies developed by companies like Oncolytics Biotech, Celcuity, Genenta Science, Sellas Life Sciences, and Amgen.

MINNEAPOLIS, June 03, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Jefferies Global Healthcare Conference to be held in New York on June 4-6, 2024.