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Stock Market & Financial Investment News

News Breaks
July 30, 2014
09:04 EDTRNA, SRPTFDA says 'willing to explore' accelerated approval for DMD drugs
In response to a White House petition urging the FDA to accelerate approval for safe, effective therapies for children with Duchenne, Janet Woodcock, Director, FDA Center for Drug Evaluation and Research, said in a response, "We are willing to explore the use of all potential pathways for the approval of drugs for Duchenne muscular dystrophy, including accelerated approval, as appropriate." She added, "We share your sense of urgency to make safe and effective drugs available for patients with Duchenne muscular dystrophy as soon as possible. That's why we're actively engaged with a number of drug companies focused on developing new drugs for Duchenne muscular dystrophy, including Sarepta Therapeutics, the company developing eteplirsen, an investigational new drug for Duchenne muscular dystrophy." Shares of Sarepta (SRPT) are trading up 5%, or 97c, to $21.30 in pre-market trading. Yesterday afternoon, Wall Street Journal reported that Sarepta is limiting the role its CEO Chris Garabedian is playing in talks with the FDA. Prosensa (RNA) is also developing a treatment for Duchenne muscular dystroph, or DMD. Reference Link
News For SRPT;RNA 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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