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Stock Market & Financial Investment News

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.
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October 27, 2014
11:06 EDTSRPTSarepta removed from the short-term buy list at Deutsche Bank
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10:59 EDTSRPTSarepta price target lowered to $21 from $37 at Piper Jaffray
Piper Jaffray lowered its price target for Sarepta shares to $21 after the FDA requested additional data for the new drug application submission of Exon 51 Duchenne Muscular Dystrophy eteplirsen. Piper says its Neutral rating on the stock reflects its belief that the current data set was not enough to support an NDA filing. Shares of the drug maker are down 34% to $15.64 in morning trading.
10:26 EDTSRPTHigh option volume stocks
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10:00 EDTSRPTSarepta approval still expected, says Needham
Needham said the FDA's request for additional data for Sarepta's NDA Duchenne muscular dystrophy treatment is a setback but the firm ultimately expects approval.
09:14 EDTSRPTOn The Fly: Pre-market Movers
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09:07 EDTSRPTFDA decision 'a major stumble' for Sarepta, says Roth Capital
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09:02 EDTSRPTProsensa may benefit most from Sarepta news, says Roth Capital
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08:50 EDTSRPTProsensa up 16% after FDA requires additional data from Sarepta
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07:48 EDTSRPTSarepta to host conference call
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07:27 EDTSRPTYoung NYC boy tested for Ebola, NY Post reports
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07:05 EDTSRPTSarepta says additional data now required for NDA submission for eteplirsen
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October 26, 2014
14:40 EDTSRPTFDA issues Emergency Use Authorization for Ebola diagnostic tests
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October 24, 2014
10:55 EDTSRPTDallas nurse now Ebola virus free, to be released, NBC reports
NBC and other media outlets cites NIH on Nina Pham's release. 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). Reference Link
October 23, 2014
15:25 EDTSRPTNew York confirms health care worker being tested for Ebola
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14:58 EDTSRPTNew York doctor rushed to hospital with Ebola-like symptoms, NY Post reports
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06:22 EDTSRPTEU to boost Ebola research with EUR 24.4M
The European Commission has today announced EUR 24.4M from the EU budget for urgently needed Ebola research. The funding will go to five projects, ranging from a large-scale clinical trial of a potential vaccine, to testing existing and novel compounds to treat Ebola. The money from Horizon 2020, the EU research and innovation program, will be provided via a fast-track procedure in order to start work as soon as possible. The Commission is also working with industry on the further development of vaccines, drugs and diagnostics for Ebola and other haemorrhagic diseases within the Innovative Medicines Initiative. The funding will be provided following proposals from teams across the EU and in numerous 3rd countries, which were evaluated by an independent group of experts. The Commission has also asked the European and Developing Countries Clinical Trials Partnership to include emerging epidemics of concern to Africa, including Ebola, in its work plan. This will allow to fund clinical trials on drugs, vaccines and diagnostics in upcoming calls. 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).
October 22, 2014
06:41 EDTSRPTWHO fast-tracking testing of two Ebola vaccines, Guardian reports
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October 20, 2014
09:09 EDTSRPTEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
October 19, 2014
16:44 EDTSRPTEbola drug discovery efforts intensify, WSJ says
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13:39 EDTSRPTCarnival cruise passenger tests negative for Ebola, Reuters says
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