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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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July 2, 2015
10:48 EDTSRPTOptions with increasing implied volatility
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June 30, 2015
10:26 EDTSRPTOptions with increasing implied volatility
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June 29, 2015
12:53 EDTSRPTSarepta NDA submission for eteplirsen done ahead of schedule, says Piper Jaffray
Piper Jaffray noted that Sarepta (SRPT) completed its rolling NDA submission for eteplirsen ahead of schedule and the firm believes that concurrent advisory committee meetings for its DMD drug and BioMarin's (BMRN) drisapersen could take place this fall. The firm has a Neutral rating and $20 price target on Sarepta and Overweight rating and $147 target on BioMarin.
07:05 EDTSRPTSarepta completes NDA submission to FDA for eteplirsen
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07:03 EDTSRPTSarepta secures $40M in debt financing
Sarepta Therapeutics announced that it entered into a credit and security agreement with Midcap Financial, a middle market-focused, specialty finance firm, that establishes a senior secured term loan facility that allows Sarepta to borrow up to $40M at an annual rate of 7.75%, with a maturity of June 2018, subject to certain conditions and other applicable fees. Sarepta has drawn down $20M under the facility and has the right to repay all borrowed funds and terminate the facility at any time.
June 26, 2015
11:00 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT AGO CRC WMB AMZN CMG TRIP ZTS AET MBI
June 25, 2015
12:59 EDTSRPTOptions with increasing implied volatility
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