Celcuity(US:CELC) Globenewswire·2025-11-26 21:05Core Insights - Celcuity Inc. announced the acceptance of an abstract for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), highlighting its ongoing research in targeted therapies for oncology [1][2]. Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications, with its lead candidate being gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor [3]. - Gedatolisib targets the PI3K/AKT/mTOR pathway, differentiating its mechanism of action and pharmacokinetic properties from other therapies that target PI3Kα, AKT, or mTORC1 alone or in combination [3]. Clinical Trials - The VIKTORIA-1 trial, a Phase 3 clinical study, has completed enrollment and is evaluating gedatolisib in combination with fulvestrant with or without palbociclib for patients with HR+/HER2- advanced breast cancer [3]. - The company has reported detailed results for the PIK3CA wild-type cohort and has also completed enrollment for the PIK3CA mutant cohort [3]. - A second Phase 3 trial, VIKTORIA-2, is currently enrolling patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer [3]. - Additionally, a Phase 1/2 trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3].