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News Breaks
April 21, 2014
07:04 EDTSRPTSarepta plans to submit NDA for Eteplirsen by year end 2014
Sarepta plans to submit a New Drug Application to the FDA by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy, or DMD. Eteplirsen is Sarepta’s lead exon-skipping drug candidate in development for the treatment of patients with DMD who have a genotype amenable to skipping of exon 51. The plan is based on a guidance letter from the Agency that proposed a strategy regarding the submission of an NDA for eteplirsen under a potential Accelerated Approval pathway. Based on the Agency’s guidance, Sarepta plans to initiate several additional clinical studies with eteplirsen later this year in exon-51 amenable genotypes.
News For SRPT From The Last 14 Days
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November 20, 2014
15:14 EDTSRPTTraveler returned from Mali being tested for Ebola in NYC, Daily News reports
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November 18, 2014
09:17 EDTSRPTSarepta announces first patient dosed in Eteplirsen study
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November 17, 2014
08:44 EDTSRPTNebraska Medical announces death of third Ebola patient
The Nebraska Medical Center said via Twitter, "We are sorry to announce that the 3rd Ebola patient, Dr. Martin Salia, has passed away as a result of the advanced symptoms of the disease." Drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Some companies that offer protective clothing and waste disposal include Lakeland Industries (LAKE), Alpha Pro Tech (APT) and Sharps Compliance (SMED).
November 12, 2014
17:20 EDTSRPTSarepta doses first patient in study of muscular dystrophy candidate Eteplirsen
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