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Sarepta released positive study results for a new treatment for Duchenne Muscular Dystrophy
Company
NASDAQ:SRPT
Sarepta Therapeutics Inc., formerly AVI BioPharma, Inc., is a biopharmaceutical company focused on the discovery and development of ribonucleic acid (RNA)-based therapeutics for the treatment of both rare and infectious diseases.
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Sarepta released positive study results for a new treatment for Duchenne Muscular Dystrophy
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Summit hopes the trial will identify utrophin modulation as a potential disease-modifying treatment for all patients suffering Duchenne Muscular Dystrophy
The company is well-placed as it looks forward to the continuation of its Phase 2 proof of concept trial for its lead utrophin modulator, ezutromid, and preparation work on its ridinilazole antibiotic
A PRV entitles the holder to a priority review of a single New Drug Application or Biologics License Application
Dr H Lee Sweeney, who led the research, said: "There remains a large unmet need in Duchenne for therapies that can treat all affected boys and slow disease progression.
We put some of your queries to life sciences research analyst Sheena Berry, of N+1 Singer, who has shed an analytical light on the licensing deal
“In our view, this deal structure is beneficial to Sarepta, with a commitment to development only after proof-of-concept data are obtained,” Wedbush said.
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The pair will collaborate on Summit’s potentially breakthrough treatment for Duchenne muscular dystrophy (DMD)
Stocks turned back after a modestly firmer opening on concerns that global interest rates could head higher sooner than expected
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Approximately 99 patients aged 7 to 13 years inclusive will be enrolled with a minimum target of 45 patients.
Shares of beleaguered Sarepta Therapeutics surged by more than one quarter on Wednesday after reports that a key critic of its muscular dystrophy medication left the US Food and Drug Administration, prompting speculation of imminent FDA app
The all important body, the FDA, has requested additional data from an ongoing study as it decides whether to approve the drug or not.
Sarepta Therapeutics shares shot 21% higher as the beleaguered company won a kind of reprieve when the regulator Food and Drug Administration said it is delaying its review of a key drug made by the firm.
All is not lost for Sarepta Therapeutics, as a report suggests the firm could still secure FDA approval for its muscular dystrophy drug previously denied by an advisory panel.
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Shares in Summit Therapeutics rose 4% after the FDA today allowed the company to broaden the scope of its phase II clinical trial of its drug ezutromid to trial sites in the US.
While not binding on the FDA, the US regulator normally takes advisory committee advice into consideration when reviewing new drug applications