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News Breaks
August 11, 2014
16:07 EDTRNAProsensa to get additional funding from nonprofit CureDuchenne
Prosensa Holding announced that an affiliate of CureDuchenne, a U.S. national nonprofit organization dedicated to finding a cure for Duchenne Muscular Dystrophy, or DMD, will provide Prosensa with up to EUR5M by means of convertible promissory notes to support the company and accelerate the development and patient access of much needed DMD therapies. The closing of EUR4.5M of the notes is contingent upon specified milestones in the advancement of drisapersen and the company's other exon skipping candidates in Prosensa's DMD portfolio. The funding arrangement will assist the company in progressing the second exon skipping candidate for the treatment of DMD, PRO044, by initiating a Phase II clinical extension study in Europe by the end of 2014 and a placebo-controlled trial in the U.S. in the first half of 2015, which may serve as one of two confirmatory studies to support a potential accelerated approval for drisapersen. It will also support re-dosing efforts for drisapersen clinical trial participants in North America and Europe and facilitate the drug's New Drug Application filing in the U.S. in 2014 along with the development of other Prosensa's other exon skipping compounds, PRO045 and PRO053.
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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.
October 10, 2014
10:12 EDTRNAProsensa begins NDA submission to FDA for drisapersen
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