Here's Why Clovis Oncology Rose as Much as 25.6% Today
Shares of Clovis Oncology (NASDAQ: CLVS) gained over 25% today after the company announced that the U.S. Food and Drug Administration (FDA) had granted priority review to Rubraca for advanced prostate cancer. The designation means that regulators will review the supplemental new drug application (sNDA) in six months or less, compared to the standard 10-month review period.
Even before today's announcement, investors never had much doubt that Rubraca would be approved to treat metastatic castration-resistant prostate cancer (mCRPC). The drug also earned Breakthrough Therapy designation from the FDA for that indication, which is usually followed by a priority review designation and often allows applications for marketing approval to be submitted based on phase 2 trial data.
However, investors might be overreacting a bit to today's news. As of 11:34 a.m. EST, the pharma stock had settled to a 13.4% gain.
Source Fool.com