Celcuity Inc.’s Promising Study on mCRPC Treatment: Key Insights for Investors

Celcuity Inc. ((CELC)) announced an update on their ongoing clinical study.

Study Overview: Celcuity Inc. is conducting a Phase 1/2 clinical study titled A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study aims to evaluate the safety, preliminary efficacy, and pharmacokinetics of the combination treatment in patients with mCRPC, a significant area of unmet medical need.

Intervention/Treatment: The study tests the combination of two drugs: Gedatolisib, a potent reversible inhibitor targeting Class I PI3K isoforms and mTOR, and Darolutamide, a novel androgen receptor inhibitor approved for certain prostate cancer treatments. The combination is intended to enhance treatment efficacy in mCRPC patients.

Study Design: This interventional study uses a randomized, parallel assignment model without masking. It includes two phases: a dose-finding phase to determine the recommended Phase 2 dose (RP2D) and a dose expansion phase to further evaluate the treatment’s effects. The primary purpose is treatment-focused.

Study Timeline: The study began on December 13, 2023. The primary completion and estimated study completion dates are not specified, but the last update was submitted on March 19, 2025. These dates are crucial for tracking progress and anticipating results.

Market Implications: The ongoing study could significantly impact Celcuity Inc.’s stock performance, given the potential breakthrough in treating mCRPC. Positive results may boost investor confidence and position the company favorably against competitors in the oncology sector. Investors should monitor updates closely as they could influence market dynamics.

The study is currently recruiting, with further details available on the ClinicalTrials portal.