CLVS stock is trading sharply higher this morning after the FDA has accepted Clovis Oncology’s (NASDAQ:CLVS) supplemental marketing application seeking approval to use Rubraca (rucaparib).
In a new development that has come as a major source of encouragement for Clovis Oncology investors, the company announced today that the United States Food and Drug Administration has granted a priority review to one of its products. The granting of a priority review is a significant development, and it comes as a massive boost for Clovis. The product in question is Rubraca, and its supplemental new drug application has also been accepted by the agency.
The priority review will make it possible for the company to get through the approval stage far more quickly. The priority review indicates that the FDA believes that if approved, the medicine could bring a significant improvement to the treatment of a particular condition.
CLVS stock soared this morning by as much as 20% to $10.69.
According to the announcement made today, the FDA is going to announce its decision on May 15 this year. Investors will, no doubt, be watching for this update closely, and it may have a positive outcome on CLVS stock.
Clovis Oncology wants to introduce Rubraca into the market as a monotherapy for people who are suffering from BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer.
The Chief Executive Officer and President of the company, Patrick J. Mahaffy, said of the development: “We are encouraged by the FDA’s decision to grant priority review to the Rubraca application, which focuses on eligible patients with advanced prostate cancer.”
The price action in CLVS stock is a clear indication that the stock has come sharply into focus during early trading today, but it remains to be seen whether it can extend its gains through the rest of the day.
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