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February 5, 2014
08:34 EDTSRPTSarepta announces Eteplirsen demonstrates stability through Phase IIb study
Sarepta Therapeutics announced new pulmonary function data through Week 120 from Study 202, a Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy. Results through more than two years of treatment showed stable pulmonary function in the Intent-to-Treat study population. These data are consistent with previously reported 120-week clinical data showing a general stabilization of walking ability in eteplirsen-treated patients evaluable on the 6-minute walk test. Results through Week 120 for other exploratory efficacy endpoints, including timed function tests and the North Star Ambulatory Assessment have shown declines compared to baseline. These endpoints are less well characterized in DMD patients than the 6MWT and pulmonary function tests and have more inter- and intra-patient variability, although they may be predictors of decline at various stages of this disease. All patients evaluable on measures of ambulation are still able to perform these tests with the exception of one patient who is no longer able to perform the Gowers’ maneuver. Eteplirsen was well tolerated through week 120 and there were no reported clinically significant treatment-related adverse events and no treatment-related serious adverse events. In addition, there were no hospitalizations or discontinuations.
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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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