FDA Approves Celcuity's Gedatolisib for Advanced Breast Cancer
CELC has more than doubled off its 52-week low of $13.365.
Summary
The FDA approved Celcuity's gedatolisib in combination with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer. This is the first regulatory approval for the company, transforming it from a clinical-stage to a commercial-stage biotech. The approval comes three days ahead of the July 17 PDUFA date, removing the key binary risk that has dominated the stock. With a $5.4 billion market cap, the approval validates the Phase 3 VIKTORIA-1 data and opens a multi-billion-dollar market opportunity. The recent $575 million convertible note offering provides ample capital for the commercial launch. Next catalyst: initial sales figures and launch metrics in the coming quarters.
At the time of this announcement, CELC was trading at $111.66 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.4B. The 52-week trading range was $13.37 to $151.02. This news item was assessed with positive market sentiment and an importance score of 10 out of 10. Source: Reuters.