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December 7, 2012
08:34 EDTSRPTSarepta updates data from Study 202 of steplirsen for treatment of DMD
Sarepta Therapeutics announced updated data from Study 202, its open-label, Phase IIb extension study of eteplirsen for the treatment of Duchenne muscular dystrophy, or DMD. Patients treated with eteplirsen for 62 weeks and evaluable on ambulatory measures maintained a statistically significant clinical benefit on the primary clinical outcome measure, the 6-minute walk test, or 6MWT, compared to patients who received placebo for 24 weeks followed by 38 weeks of eteplirsen treatment. The mITT consisted of 10 of the enrolled 12 patients, and excludes two patients who showed signs of rapid disease progression and lost ambulation by week 24. The placebo/delayed-treatment cohort (n=4) also demonstrated stability in walking distance from week 36 through week 62 with a less than 10 meter change over this timeframe, the period in which dystrophin was likely produced, with confirmation of significant dystrophin levels at week 48 through analysis of muscle biopsies in these patients.
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June 19, 2013
11:13 EDTSRPTSarepta rises after reporting clinical data
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09:54 EDTSRPTSarepta data supports accelerated approval, says Piper Jaffray
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08:39 EDTSRPTSarepta eteplirsen demonstrates benefit on walking test in Phase IIb study
Sarepta Therapeutics announced updated data from Study 202, a Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy, or DMD. Results at 84 weeks showed a continued stabilization of walking ability in eteplirsen-treated patients evaluable on the 6-minute walk test. As previously reported, Study 202 met its primary endpoint of increased novel dystrophin as assessed by muscle biopsy at Week 48 and is now in the long-term extension phase in which patients continue to be followed for safety and clinical outcomes. Eteplirsen is Sarepta's lead exon-skipping compound in development for the treatment of patients with DMD who have a genotype amenable to skipping of exon 51.
June 17, 2013
12:20 EDTSRPTOptions with increasing implied volatility: WLT LNCO SRPT LINE
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June 14, 2013
11:23 EDTSRPTOptions with increasing implied volatility: TWO SRPT LNCO LINE DVA
06:15 EDTSRPTLeerink remains cautious on accelerated approval for Sarepta
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June 5, 2013
13:29 EDTSRPTOptions with decreasing implied volatility: INFI SRPT GES SUPN CPRT
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