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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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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.
August 7, 2014
07:38 EDTSRPTSarepta reports Q2 EPS (61c), consensus (76c)
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