Celcuity Expands Phase 3 Breast Cancer Trial for Gedatolisib to Include Endocrine-Sensitive Patients
CELC has more than doubled off its 52-week low of $9.51.
Summary
Celcuity has expanded its Phase 3 VIKTORIA-2 clinical trial for gedatolisib, a breast cancer treatment, to include endocrine-sensitive patients. This development significantly broadens the potential addressable market for the drug, enhancing its commercial prospects. This news follows recent positive topline results from the VIKTORIA-1 trial for gedatolisib and the FDA's grant of Priority Review with a PDUFA date of July 17, 2026, for the drug. The expansion is a material positive step in the drug's development, and traders will now monitor the progress of this new cohort alongside the upcoming PDUFA decision.
At the time of this announcement, CELC was trading at $133.47 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6.5B. The 52-week trading range was $9.51 to $151.02. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Dow Jones Newswires.