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Sarepta Down, Eteplirsen Likely to Face FDA Panel in Jan

Sarepta Therapeutics, Inc.SRPT announced that its Duchenne muscular dystrophy (DMD) candidate, eteplirsen, will be reviewed by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee tentatively on Jan 22, 2016. Though the FDA action date remains unchanged (Feb 26, 2016), the FDA panel date will be confirmed either through a formal communication (written) to the company or through a notice that will be published in the Federal Register.

We note that BioMarin Pharmaceutical Inc.'s BMRN DMD candidate, drisapersen, will be reviewed by the FDA's advisory panel on Nov 24, 2015.

While Sarepta's shares plunged 11.8% on the news, BioMarin's shares gained 4.5%. The news that Sarepta's eteplirsen will not be reviewed by the FDA's advisory panel at the same time as BioMarin's DMD candidate has shook investors - it was generally expected that both drugs would have been reviewed on the same day or on consecutive days, irrespective of the fact that BioMarin had submitted its regulatory application two months (Apr 2015) ahead of Sarepta (Jun 2015).

Considering the latest development, it is evident that BioMarin could have a two-month head start if approval comes on schedule. The FDA is expected to render a decision on drisapersen by Dec 27, 2015.

We expect investor focus to remain on the upcoming advisory panel meeting and approval status of eteplirsen.

Sarepta is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are AstraZeneca plc AZN and Endo International plc ENDP . Both carry a Zacks Rank #1 (Strong Buy).

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ASTRAZENECA PLC (AZN): Free Stock Analysis Report

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BIOMARIN PHARMA (BMRN): Free Stock Analysis Report

SAREPTA THERAP (SRPT): 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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