Clovis Oncology, Inc. CLVS reported two important developments on the regulatory front related to its lead pipeline candidate, rociletinib. Clovis announced that its new drug application for rociletinib has been accepted for priority review by the FDA, which means a response should be out by Mar 30, 2016.
Clovis is looking to get the candidate approved for the treatment of patients suffering from mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
We note that rociletinib has also been granted Breakthrough Therapy designation by the FDA.
In addition, Clovis announced that its marketing authorization application for rociletinib has been accepted for review by the European Medicines Agency (EMA) for the same indication and has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use.
We note that accelerated assessment is granted to treatments that are considered to be of major public health interest in the EU, given the importance of therapeutic innovation in a patient population that exhibits a high unmet need. The given designation will shorten the review period from 210 days to 150 days.
We are encouraged by the company hitting two regulatory milestones simultaneously. We expect investors to react positively to the news.
With no approved product in its portfolio at the moment and rociletinib being the lead pipeline candidate, we expect investor focus to remain on its approval status.
Clovis is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Regeneron Pharmaceuticals, Inc. REGN, Teva Pharmaceutical Industries Limited TEVA and Amgen Inc. AMGN. While Regeneron is a Zacks Rank #1 (Strong Buy) stock, Teva and Amgen hold a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
REGENERON PHARM (REGN): Free Stock Analysis Report
AMGEN INC (AMGN): Free Stock Analysis Report
TEVA PHARM ADR (TEVA): Free Stock Analysis Report
CLOVIS ONCOLOGY (CLVS): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research