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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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17:06 EDTSRPTSarepta announce publication of Phase I clinical data of AVI-7288
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July 20, 2015
14:32 EDTSRPTFDA panel likely to review Sarepta, BioMarin drugs in November, TheStreet says
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11:03 EDTSRPTSarepta rises after Roth says added data can keep it ahead of BioMarin
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10:13 EDTSRPTOptions with decreasing implied volatility
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