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Sarepta's Eteplirsen Receives Accelerated FDA Approval, Shares Soar 80%
Monday, September 19, 2016 - 10:18am | 318Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) soared more than 80 percent Monday morning after the U.S. Food and Drug Administration confirmed in a letter it granted the company with an accelerated approval for its Eteplirsen drug. Sarepta's drug is intended for the treatment of...
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SunTrust On Sarepta Therapeutics: FDA Likely To Deny Approval For Eteplirsen
Wednesday, September 14, 2016 - 3:27pm | 390SunTrust said the "logical decision" for the FDA would be to deny approval for Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Eteplirsen drug for the treatment of Duchenne Muscular Dystrophy. DMD is a genetic disorder caused by an absence of dystrophin, a protein that helps keep muscle...
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Farkas' FDA Departure Could Signal 'Imminent Decision' For Eteplirsen
Wednesday, September 14, 2016 - 10:08am | 304Checks indicate that Dr. Ronald Farkas has left the FDA and his name no longer appeared in the HHS employee directory. Oppenheimer’s Michelle Gilson said this was “a positive signal for eteplirsen approval” and maintained an Outperform rating on Sarepta Therapeutics Inc (...
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JMP On Sarepta: 'We Maintain Our 10% Chance Of First-Cycle Approval For Eteplirsen'
Wednesday, September 14, 2016 - 8:56am | 272Benzinga has learned that Dr. Ronald Farkas, leader of the clinical team for Sarepta Therapeutics Inc’s (NASDAQ: SRPT) Eteplirsen NDA, has left the FDA. This may lend upside to the company’s shares “due to a read-through that is another step toward approval,” JMP...
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Exclusive: Dr. Ron Farkas, Eteplirsen's Harshest Critic, Has Left The FDA
Tuesday, September 13, 2016 - 8:46pm | 451The "miracle drug" that could save the lives and well-being for hundreds of people may have just received some great news. Dr. Ron Farkas has left the U.S. Food & Drug Administration, people familiar with the matter told Benzinga. Why would his departure raise hope for the "...