Celcuity Inc. ((CELC)) announced an update on their ongoing clinical study.
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Celcuity Inc. is conducting a Phase 3 clinical study titled VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer. The study aims to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant and CDK4/6 inhibitors for treating advanced breast cancer, which could significantly impact treatment protocols for this condition.
The intervention being tested is gedatolisib, an experimental drug administered intravenously, combined with fulvestrant and CDK4/6 inhibitors like palbociclib or ribociclib. This combination is intended to enhance treatment efficacy for patients with HR-positive, HER2-negative advanced breast cancer.
The study employs a randomized, parallel assignment model with no masking, focusing on treatment as its primary purpose. Participants are divided into two groups: one receiving gedatolisib with other drugs and the other receiving only the standard treatment of palbociclib or ribociclib with fulvestrant.
The study began on December 24, 2024, with its primary completion expected in 2025. The latest update was submitted on June 14, 2025, indicating ongoing recruitment and progress in the study.
This study update could influence Celcuity’s stock performance positively if results show significant benefits, potentially increasing investor interest. The study’s progress is crucial as it positions Celcuity against competitors in the breast cancer treatment market, where innovation is key.
The study is ongoing, with further details available on the ClinicalTrials portal.