Celcuity Publishes Phase 3 Gedatolisib Trial Results in Journal of Clinical Oncology

Key Facts

1Celcuity announced the publication of efficacy and safety results from the Phase 3 VIKTORIA-1 study in the Journal of Clinical Oncology (JCO).

2The study focuses on gedatolisib for HR+/HER2- advanced breast cancer in patients with PIK3CA wild-type.

3The trial included patients who progressed after treatment with CDK4/6 inhibitors and aromatase inhibitors.

Celcuity Inc. (Nasdaq: CELC) announced the publication of efficacy and safety results from its Phase 3 VIKTORIA-1 study in the prestigious Journal of Clinical Oncology (JCO). The study evaluates the performance of gedatolisib, the company's lead drug candidate, for treating HR+/HER2- advanced breast cancer. Specifically, the trial focused on patients with PIK3CA wild-type who experienced disease progression following treatment with CDK4/6 and aromatase inhibitors. This peer-reviewed validation is a significant milestone for the clinical-stage biotech firm, providing essential data for its regulatory advancement. Market sentiment remains bullish as the publication strengthens investor confidence in Celcuity's clinical pipeline and its path toward potential FDA approval. The successful dissemination of these results underscores the therapeutic potential of gedatolisib in addressing unmet needs in oncology.