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News Breaks
August 12, 2014
12:24 EDTRNAProsensa accelerated or conditional approvals likely, says Roth Capital
Roth Capital said its is "increasingly optimistic" that regulators won't focus on the outcome of Prosensa's disappointing phase 3 study for drisapersen and are likely to consider the totality of the data given the rare disease setting. The firm believes accelerated or conditional approvals for the drug are likely and it reiterates its Buy and $17 price target on the stock.
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October 27, 2014
16:36 EDTRNAOn The Fly: Closing Wrap
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12:30 EDTRNASarepta dives after FDA requests additional data on DMD drug
Shares of drug maker Sarepta (SRPT) are plunging after the FDA said the company would have to submit more data on its Duchenne muscular dystrophy, or DMD, drug before the agency would consider approving the treatment. WHAT'S NEW: The FDA informed Sarepta that it would have to submit additional data on its DMD drug, eteplirsen, before filling an application for FDA approval of the drug, Sarepta reported this morning. The FDA wants several additional data points, including four more weeks of data on 12 patients taking eteplirsen and three month data on 12-24 additional patients. The agency also requested MRI data on patients from a recent study conducted by an independent academic group. After reviewing the agency's requests, Sarepta said it expected to file a new application for approval of eteplirsen in the middle of next year. ANALYST REACTION: In a note to investors earlier today, Piper Jaffray analyst Edward Tenthoff wrote that the FDA is concerned about quality control issues involving the company's staining and analysis of dystrohpin, a protein that boosts muscle strength. DMD is triggered by errors in the gene that governs dystrohpin, and Sarepta has used dystrophin production levels as a primary endpoint for the evaluation of eteplirsen. The earliest that the drug could be approved by the FDA is 2016, wrote the analyst, who slashed his price target on the shares to $21 from $37. The FDA was not convinced of Sarepta's contention that dystrophin was an appropriate way to measure eteplirsen's effectiveness, Roth Capital contended. The firm does not expect Sarepta's drug to be approved until the first quarter of 2016 at the earliest. Roth says that its Buy rating and $34 price target on the name are under review. WHAT'S NOTABLE: Shares of Prosensa (RNA), which has also developed a DMD treatment, are climbing. Prosensa is due to file for FDA approval of its drug by the end of the year. According to Roth Capital, Prosensa has not relied on dystrophin levels to prove the effectiveness of its treatment. PRICE ACTION: In early afternoon trading, Sarepta tumbled 35% to $15.39, while Prosensa climbed 6% to $12.73.
12:27 EDTRNAOn The Fly: Midday Wrap
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09:14 EDTRNAOn The Fly: Pre-market Movers
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09:02 EDTRNAProsensa may benefit most from Sarepta news, says Roth Capital
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08:50 EDTRNAProsensa up 16% after FDA requires additional data from Sarepta
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October 20, 2014
06:50 EDTRNAProsensa upgraded to Overweight from Underweight at JPMorgan
JPMorgan upgraded Prosensa two notches to Overweight citing a favorable risk/reward around the potential approval of Drisapersen for Duchenne muscular dystrophy. The firm believes regulatory risk for the drug has been significantly reduced in both the U.S. and Europe. JPMorgan raised its price target for shares to $18 from $4.40.

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