Celcuity (CELC) Expands Phase 3 VIKTORIA-2 Trial to Include Endocrine-Sensitive Breast Cancer Patients

Celcuity Inc. (NASDAQ:CELC) is one of the best high short interest stocks with highest upside potential. On May 14, Celcuity announced amendments to its Phase 3 VIKTORIA-2 clinical trial, which evaluates gedatolisib as a first-line treatment for hormone receptor-positive, HER2-negative advanced breast cancer. The study will now expand to include a separate cohort for endocrine-sensitive patients, in addition to the original focus on endocrine-resistant cases.

Each study will operate with independent statistical plans, targeting progression-free survival as the primary endpoint. This expansion follows encouraging Phase 1b results, which showed high efficacy in endocrine-sensitive patients compared to existing standard-of-care regimens. By including both endocrine-sensitive and endocrine-resistant populations, Celcuity aims to position its gedatolisib triplet therapy as a broad-spectrum treatment option for the ~90,000 women diagnosed with late-stage HR+/HER2- breast cancer annually.

In parallel with its clinical trial updates, Celcuity Inc. (NASDAQ:CELC) is advancing the long-term development of gedatolisib by pursuing a new subcutaneous formulation. The company has filed its first patent application for this injectable version, which is intended to offer a more convenient alternative to intravenous administration for patients requiring multi-year treatment.

Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotech company that develops targeted oncology therapies for solid tumors. Their lead candidate, gedatolisib, is a kinase inhibitor of the PAM pathway undergoing multiple clinical trials.

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