Clovis Oncology CLVS Stock News

Clovis Oncology Inc (NASDAQ: CLVS) is making a run for the top in the market this morning, gaining more than 25% in the premarket after announcing that the FDA has granted Priority Review. Here’s what’s going on:

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CLVS Stock Pops On Priority Review

In a premarket press release, Clovis Oncology said that the United States Food and Drug Administration has accepted its supplemental New Drug Application for Rubraca. Importantly, the FDA has granted priority review status on the application.

The PDUFA date, or date when the FDA will make its decision to approve or reject Rubraca, is May 15, 2020. With the sNDA, CLVS aims to bring Rubraca to the market as a monotherapy for adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer.

In a statement, Patrick J. Mahaffy, President and CEO at CLVS, had the following to offer:

Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and this filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available. 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, for whom new treatment options are very much needed.

This Is Incredibly Exciting News

There’s good reason that investors are so excited about the news issued by Clovis Oncology today. First and foremost, Priority Review status is a big deal. As a result of the Priority Review, the PDUFA date was set to six months from acceptance, rather than ten months.

Moreover, the fact that the FDA has granted priority review tells us something about the market for this indication. Priority review is only granted when the treatment addresses an indication that is in serious need of options.

It’s also worth mentioning that the castration-resistant prostate cancer market is expected to grow to be worth $11.5 billion annually by the year 2025. Considering the lack of current options and the massive size of the market, if this drug is approved, it could quickly become a blockbuster, yielding tremendous profits for CLVS and its investors.

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