Celcuity reports positive Phase 1 data for prostate cancer therapy

MINNEAPOLIS - Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company with a market capitalization of $2.2 billion, announced updated clinical results from the Phase 1 portion of its trial evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer (mCRPC) who had progressed on prior treatment. The company’s stock has shown remarkable momentum, surging over 400% in the past six months, according to InvestingPro data.

The study showed a median radiographic progression-free survival (rPFS) of 9.1 months and a six-month rPFS rate of 67% across both dosing arms. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% with a median rPFS of 9.5 months, while those receiving 180 mg gedatolisib showed a six-month rPFS rate of 61% with a median rPFS of 7.4 months. With analyst price targets ranging from $60 to $110 and the company’s next earnings report due November 17, investors seeking deeper insights can access comprehensive analysis through InvestingPro’s detailed research reports.

The trial enrolled 38 patients, with 61% having received one line of prior systemic therapy and 39% having received two or more lines of prior therapy. Patients were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg or 180 mg gedatolisib.

According to the company, the combination therapy was generally well tolerated with mostly low-grade treatment-related adverse events. No dose-limiting toxicities were observed, and no patients discontinued treatment due to adverse events. The only Grade 3 treatment-related adverse events included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%).

"The 67% six-month rPFS rate and median rPFS of 9.1 months for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting," said Igor Gorbatchevsky, Chief Medical Officer of Celcuity, according to the press release.

The company is now enrolling patients in its updated Phase 1/1b portion of the clinical trial to determine the recommended Phase 2 dose. While Celcuity maintains a strong liquidity position with a current ratio of 4.58, InvestingPro analysis indicates the stock may be trading above its Fair Value. Investors can access 15+ additional ProTips and comprehensive biotech sector metrics through InvestingPro’s research platform.

In other recent news, Celcuity Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for gedatolisib for review under the Real-Time Oncology Review program. This development is based on topline data from the Phase 3 VIKTORIA-1 clinical trial, with a complete NDA submission expected by the fourth quarter of 2025. Additionally, Celcuity has secured a $500 million credit facility to support cancer drug development, with $350 million in committed capital and an initial funding of $30 million already received. In another development, Guggenheim initiated coverage on Celcuity with a Buy rating, citing significant sales potential for gedatolisib in second-line breast cancer treatment. H.C. Wainwright also raised its price target for Celcuity to $66 from $50 while maintaining a Buy rating, following the company’s second-quarter 2025 financial results. Celcuity is also set to present detailed data from its Phase 3 VIKTORIA-1 trial at the European Society of Medical Oncology Congress. These recent developments highlight significant progress in Celcuity’s drug development and financial strategies.

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