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News Breaks
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.
News For SRPT From The Last 14 Days
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January 25, 2015
13:57 EDTSRPTUK nurse make full recovery from Ebola, WSJ says
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January 23, 2015
10:02 EDTSRPTOn the Fly: Analyst Initiation Summary
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January 22, 2015
16:15 EDTSRPTSarepta initiated with a Sector Perform at RBC Capital
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January 21, 2015
10:01 EDTSRPTOn The Fly: Analyst Downgrade Summary
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06:59 EDTSRPTSarepta downgraded to Neutral from Outperform at Wedbush
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January 15, 2015
15:26 EDTSRPTSarepta says no safety info or comparison in BioMarin presentation
Sarepta (SRPT) said that, given the small sample size of study 201/202, the company understood the importance of providing an "extensive amount of date" in order to understand eteplirsen's treatment effect. Sarepta has reported mITT data since week 24 and has continued to provide updates on this same mITT at every timepoint, the company said. BioMarin's (BMRN) presentation on Monday focused on extension phase and excluded dose-escalation phase and results during off-treatment periods, according to Sarepta. "Sarepta has regularly reported complete 201/202 safety data on all patients. No safety information or comparison [was included] in BioMarin's Monday presentation," Sarepta wrote in slides for its presentation at the JPMorgan Healthcare Conference.
07:13 EDTSRPTJPMorgan to hold a conference
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January 14, 2015
08:30 EDTSRPTSarepta says first patient dosed in European Phase 1/II SRP-4053 study
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