FDA Approves Celcuity's REVTORPYK for Breast Cancer, Launch Set for Late Q3
CELC has more than doubled off its 52-week low of $13.365.
Summary
The FDA approved Celcuity's REVTORPYK (gedatolisib) for HR+/HER2- metastatic breast cancer without a PIK3CA mutation, following yesterday's initial approval report. The drug showed a 76% reduction in progression/death risk in the triplet regimen, with median PFS of 9.3 vs 2.0 months. Celcuity plans a late Q3 commercial launch and will submit an sNDA in Q3 for the PIK3CA-mutant cohort. This approval validates the company's lead asset and opens a significant market opportunity, though the stock already reacted sharply to the news yesterday.
At the time of this announcement, CELC was trading at $106.00 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 8 out of 10. Source: Wiseek News.