Allergan, Inc. (AGN), Theravance Inc (THRX), GlaxoSmithKline plc (ADR) (GSK) & The Week, Biotech

Finally, Sarepta Therapeutics Inc (NASDAQ:SRPT) found itself on the short end of the stick after it announced what investors construed as mixed results from a discussion with the FDA over its Duchenne muscular dystrophy drug hopeful, eteplirsen. Sarepta Therapeutics Inc (NASDAQ:SRPT) is attempting to gain accelerated approval for its DMD drug following exemplary mid-stage test results, but first the FDA would first like the company to justify why dystrophin (a protein whose production is encouraged by taking eteplirsen) should be an acceptable endpoint and predictor of clinical benefit. It also requested additional safety data as part of the accelerated review process. Some on the Street have seen this as the FDA’s unwillingness to approve a drug that’s been tested on such a small sample size. Then again, the FDA’s wish to review additional data, should Sarepta Therapeutics Inc (NASDAQ:SRPT) meet its request, signifies to other investors its willingness to possibly push eteplirsen through the process.

The article This Week in Biotech: Part 1 originally appeared on Fool.com is written by Sean Williams.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.The Motley Fool has no position in any of the stocks mentioned.

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