MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2025 after the market closes on Wednesday, November 12, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate i ...

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR ("PAM") pathway comprehensively [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [3] Clinical Trials - The Phase 3 clinical trial VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, has completed enrollment and reported results for the PIK3CA Wild-Type cohort [3] - Enrollment for the PIK3CA mutant cohort in the VIKTORIA-1 trial has also been completed [3] - The ongoing Phase 3 clinical trial VIKTORIA-2 is evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC [3] - A Phase 1/2 clinical trial, CELC-G-201, is currently evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer [3] Upcoming Events - Brian Sullivan, CEO and Co-founder of Celcuity, is scheduled for a fireside chat at the Stifel 2025 Healthcare Conference on November 11, 2025, at 10:00 a.m. ET [2] - A live webcast of the event will be available on the company's website [2]

Core Insights - Celcuity Inc. is set to disclose topline results from the Phase 3 VIKTORIA-1 trial on July 28, 2025 [1][2] - The company focuses on developing targeted therapies for oncology, particularly for solid tumors [3] Company Overview - Celcuity is a clinical-stage biotechnology company headquartered in Minneapolis [3] - The lead therapeutic candidate is gedatolisib, a pan-PI3K and mTORC1/2 inhibitor, which targets the PAM pathway [3] - Ongoing clinical trials include VIKTORIA-1 for HR+/HER2- advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [3]

Core Insights - Celcuity Inc. has initiated the Phase 3 clinical trial VIKTORIA-2 to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant for HR+/HER2- advanced breast cancer patients who are resistant to endocrine therapy [1][2][3] Group 1: Clinical Trial Details - The VIKTORIA-2 trial is an open-label, randomized study comparing the efficacy and safety of gedatolisib combined with fulvestrant and a CDK4/6 inhibitor against the standard treatment of fulvestrant and a CDK4/6 inhibitor [3][4] - Approximately 638 subjects will be enrolled, with random assignment to either the experimental group (gedatolisib, fulvestrant, and a CDK4/6 inhibitor) or the control group (fulvestrant and a CDK4/6 inhibitor) [4] - The trial will assess primary endpoints of progression-free survival (PFS) based on RECIST 1.1 criteria, evaluated separately for PI3KCA wild type and mutant subjects [4] Group 2: Efficacy and Safety - Previous Phase 1b trial results indicated that patients receiving gedatolisib with palbociclib and letrozole had a median progression-free survival of 48.6 months and median overall survival of 77.3 months, with an objective response rate of 79% [2] - The trial aims to provide robust data to support the potential of gedatolisib as a first-line treatment option for patients with endocrine-resistant advanced breast cancer [2][3] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5][6] - The company is headquartered in Minneapolis and is also conducting other clinical trials, including VIKTORIA-1 and CELC-G-201, targeting different cancer types [5][6]