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News Breaks
February 10, 2014
08:31 EDTSRPTSarepta reports results from Phase 1 study of Marburg drug candidate
Sarepta Therapeutics announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers. AVI-7288, which uses Sarepta’s advanced and proprietary PMOplus chemistry, is the company’s lead drug candidate for the treatment of Marburg virus infection. Sarepta has been developing AVI-7288 under a Department of Defense contract managed by the Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. The Phase I clinical study was a randomized, double-blind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing. In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days. Results showed that AVI-7288 was well tolerated through the highest dose tested, 16 mg/kg per day, which is higher than the anticipated therapeutic dose, with no reported serious or clinically significant adverse events. An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288.
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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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