Celcuity Inc.’s Promising Phase 3 Breast Cancer Study: A Market Game-Changer?

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

Study Overview: Celcuity Inc. is conducting a Phase 3 clinical trial titled Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy. The study aims to evaluate the efficacy and safety of gedatolisib plus fulvestrant, with or without palbociclib, in treating advanced or metastatic HR+/HER2- breast cancer, a significant concern for patients who have progressed after previous treatments.

Intervention/Treatment: The study tests several interventions: Gedatolisib, a drug administered intravenously; Palbociclib, an oral medication; Fulvestrant, given via intramuscular injection; and Alpelisib, another oral drug. These interventions target different pathways to inhibit cancer progression.

Study Design: This is an interventional study with a randomized allocation and a parallel intervention model. It is open-label, meaning no masking is involved, and its primary purpose is treatment-focused, aiming to assess the effectiveness of the drug combinations.

Study Timeline: The study began on August 12, 2022, and the latest update was submitted on June 23, 2025. These dates are crucial as they indicate the study’s progression and the timeline for potential results.

Market Implications: This study’s update could significantly impact Celcuity Inc.’s stock performance, as positive results may boost investor confidence and position the company favorably against competitors in the breast cancer treatment market. The ongoing research highlights Celcuity’s commitment to advancing cancer therapies, which could enhance its market standing.

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