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Stock Market & Financial Investment News

News Breaks
April 21, 2014
07:04 EDTSRPTSarepta plans to submit NDA for Eteplirsen by year end 2014
Sarepta plans to submit a New Drug Application to the FDA by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy, or DMD. Eteplirsen is Sarepta’s lead exon-skipping drug candidate in development for the treatment of patients with DMD who have a genotype amenable to skipping of exon 51. The plan is based on a guidance letter from the Agency that proposed a strategy regarding the submission of an NDA for eteplirsen under a potential Accelerated Approval pathway. Based on the Agency’s guidance, Sarepta plans to initiate several additional clinical studies with eteplirsen later this year in exon-51 amenable genotypes.
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September 19, 2014
15:20 EDTSRPTSarepta sees start of large DMD trial delayed, Boston Business Journal reports
Sarepta CEO Chris Garabedian previously has said that dosing in a large confirmatory trial for its Duchenne muscular dystrophy drug eteplirsen would begin before the end of September, but he now sees dosing to begin in October or November due to delays “outside the company” with contract research and manufacturing partners, according to Boston Business Journal, citing an interview with the executive. Shares of Sarepta are down 4% in afternoon trading following the report. Reference Link
15:16 EDTSRPTSarepta CEO says start of main DMD trial delayed, Boston Business Journal says
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September 11, 2014
10:20 EDTSRPTNebraska Medical Center not naming Ebola drug, The Street reports
Nebraska Medical Center is not releasing the name of the experimental Ebola drug being given to Dr. Rick Sacra, The Street's Adam Feuerstein reports, citing an emailed response from the hospital. Traders are speculating Tekmira (TKMR) is the manufacturer of the drug, Feuerstein points out. Sarepta (SRPT) disclosed that it is not involved in the treatment of Sacra, added Feuerstein. Shares of Tekmira are up 3% to $19.65 in morning trading. Reference Link

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