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Stock Market & Financial Investment News

News Breaks
April 16, 2013
10:20 EDTSRPTSarepta tumbles after FDA requests more data on drug
Shares of Sarepta Therapeutics (SRPT) are sinking after the company announced that the FDA had requested additional information about its eteplirsen treatment for Duchenne muscular dystrophy, or DMD. WHAT'S NEW: The FDA requested that Sarepta provide a summary explaining why dystrophin, the production of which is supposed to be stimulated by eteplirsen, is an acceptable therapy for DMD, Sarepta announced last night. The FDA also requested detailed information about the clinical trials of eteplirsen, and indicated that it would need the information in order to help determine whether the drug is eligible for accelerated approval, according to Sarepta. The company said that it was "encouraged" by its discussions with the FDA. ANALYST REACTION: In a note to clients, Piper Jaffray analyst Edward Tenthoff wrote that the FDA's request indicates that the agency is looking to find a way to grant the drug accelerated approval. There is now a greater than 50/50 chance that Sarepta will be able to file for approval of the drug based on existing data, the analyst believes, adding that such a development should cause the stock to advance significantly. If, on the other hand, Sarepta is required to conduct a Phase III clinical trial of the drug before obtaining FDA approval for it, the resulting drop in the stock will create a buying opportunity, added Tenthoff. The analyst increased his price target on the shares to $50 from $35 and reiterated an Overweight rating on the stock. TODAY'S PRICE ACTION: In mid-morning trading, Sarepta fell $5.65, or 14.4%, to $33.50.
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August 21, 2014
09:01 EDTSRPTSarepta enters into partnership with Flagship Biosciences
Sarepta Therapeutics and Flagship Biosciences announced a multi-year, multi-product partnership for the development of automated quantitative endpoint measurements in muscular dystrophy to support the advancement of Sarepta’s Duchenne muscular dystrophy drug pipeline, including its lead candidate, eteplirsen. This newly established collaboration with Flagship demonstrates Sarepta’s commitment to enhancing the objective measurement of dystrophin in tissue samples for its growing pipeline of RNA-based therapeutics to treat DMD.

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