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BioMarin's Drisapersen to be Reviewed by FDA's Committee

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BioMarin Pharmaceutical Inc .'s BMRN shares were up 7.4% immediately after the company announced that its New Drug Application (NDA) for drisapersen will be reviewed by the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA on Nov 24, 2015. Although, shares declined 2.4% in the next trading session, overall shares were up 4.8%.

BioMarin is seeking approval for drisapersen for the treatment of patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

Drisapersen has Orphan drug and Fast Track status, Breakthrough Therapy and Rare Pediatric Disease designation in the U.S.

According to information provided by the company, approximately 1 in every 3,500-5,000 live male births is diagnosed with DMD. The company estimates that there are approximately 2,000 patients in the U.S. who can be treated with drisapersen.

Meanwhile, BioMarin continues to progress with the development of other DMD treatments. Currently, three phase II studies are ongoing on BMN 044, BMN 045 and BMN 053 for the treatment of DMD patients with exon skippers 44, 45 and 53, respectively.

We remind investors that Sarepta Therapeutics, Inc.'s SRPT DMD candidate, eteplirsen, will be reviewed by the FDA's advisory panel on Jan 22, 2016. A response from the FDA is expected by Feb 26, 2016.

BioMarin carries a Zacks Rank #2 (Buy). A couple of favorably ranked stocks in the health care sector include Nexvet Biopharma Public Limited Company NVET and Anika Therapeutics Inc. ANIK , each sporting a Zacks Rank #1 (Strong Buy).

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BIOMARIN PHARMA (BMRN): Free Stock Analysis Report

ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

SAREPTA THERAP (SRPT): Free Stock Analysis Report

NEXVET BIOPHARM (NVET): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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