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News Breaks
February 5, 2014
08:34 EDTSRPTSarepta announces Eteplirsen demonstrates stability through Phase IIb study
Sarepta Therapeutics announced new pulmonary function data through Week 120 from Study 202, a Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy. Results through more than two years of treatment showed stable pulmonary function in the Intent-to-Treat study population. These data are consistent with previously reported 120-week clinical data showing a general stabilization of walking ability in eteplirsen-treated patients evaluable on the 6-minute walk test. Results through Week 120 for other exploratory efficacy endpoints, including timed function tests and the North Star Ambulatory Assessment have shown declines compared to baseline. These endpoints are less well characterized in DMD patients than the 6MWT and pulmonary function tests and have more inter- and intra-patient variability, although they may be predictors of decline at various stages of this disease. All patients evaluable on measures of ambulation are still able to perform these tests with the exception of one patient who is no longer able to perform the Gowers’ maneuver. Eteplirsen was well tolerated through week 120 and there were no reported clinically significant treatment-related adverse events and no treatment-related serious adverse events. In addition, there were no hospitalizations or discontinuations.
News For SRPT From The Last 14 Days
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October 1, 2014
06:26 EDTSRPTSarepta volatility flat into CDC confirms first U.S. Ebola case in Texas
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September 30, 2014
18:36 EDTSRPTOn The Fly: After Hours Movers
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17:58 EDTSRPTCDC confirms first U.S. patient diagnosed with Ebola virus
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17:39 EDTSRPTCompanies developing Ebola treatments rise after CDC confirms U.S. Ebola case
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17:36 EDTSRPTSarepta CEO says would need funding to complete larger order of Ebola drug
17:31 EDTSRPTSarepta CEO says has not received formal request for Ebola drug
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17:01 EDTSRPTSarepta up 4% after hours following CDC confirmation of Ebola case in U.S.
12:20 EDTSRPTSarepta AVI-7100 safety results a positive across franchise, says Credit Suisse
Credit Suisse said Outperform rated Sarepta's AVI-7100 positive Phase 1 safety results has positive implications across its anti-infective franchise. The firm said success in one or more of the infectious disease programs will drive upside to its $36 price target valuation.
07:32 EDTSRPTSarepta announces favorable safety results from Phase 1 AVI-7100 study
Sarepta Therapeutics announced favorable safety results from the single ascending dose portion of a Phase I study of AVI-7100, the company’s lead candidate for the treatment of influenza virus, in healthy volunteers. The clinical trial is being conducted at the National Institutes of Health (NIH) through a collaboration between the company and the NIH’s National Institute of Allergy and Infectious Diseases. AVI-7100 uses Sarepta’s advanced and proprietary PMOplus chemistry, which is also the basis of the company’s clinical-stage Ebola and Marburg drug candidates. The Phase I clinical study is a randomized, double-blind, placebo-controlled trial designed to characterize the safety, tolerability and pharmacokinetics of single and multiple doses of an intravenous formulation of AVI-7100 in healthy adult volunteers. In the completed single ascending dose portion, 40 subjects were enrolled in five cohorts up to the highest dose tested of 8 mg/kg AVI-7100. Results showed that AVI-7100 was well-tolerated with no reported serious or clinically significant adverse events. The pharmacokinetic analysis of AVI-7100 reveals a highly similar dose-dependent profile to that of Sarepta’s Ebola and Marburg PMOplus drug candidates. An independent Data and Safety Monitoring Board reviewed safety results from the study and recommended the study continue as planned to the multiple dose portion of the study.
September 26, 2014
07:47 EDTSRPTEMA to review BioCryst, Sarepta, Tekmira experimental Ebola medicines
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September 24, 2014
09:59 EDTSRPTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Ameren (AEE) initiated with a Buy at Ladenburg... Autoliv (ALV) initiated with an Outperform at Exane BNP Paribas... BNY Mellon (BK) initiated with a Neutral at Citigroup... Burlington Stores (BURL) initiated with a Neutral at Credit Suisse... Cameron (CAM) initiated with a Market Perform at Wells Fargo... CoreLogic (CLGX) initiated with an Overweight at Piper Jaffray... FMC Technologies (FTI) initiated with a Market Perform at Wells Fargo... FNFV (FNFV) initiated with a Neutral at Piper Jaffray... Fidelity National (FNF) initiated with an Overweight at Piper Jaffray... First American (FAF) initiated with a Neutral at Piper Jaffray... Freeport McMoRan (FCX) initiated with an Outperform at Scotia Capital... Helmerich & Payne (HP) initiated with an Outperform at Wells Fargo... HomeAway (AWAY) initiated with a Buy at SunTrust... IMS Health (IMS) initiated with a Buy at Topeka... Nabors Industries (NBR) initiated with an Outperform at Wells Fargo... National Oilwell (NOV) initiated with a Market Perform at Wells Fargo... Northern Trust (NTRS) initiated with a Neutral at Citigroup... Pacific Drilling (PACD) initiated with a Market Perform at Wells Fargo... Paragon Offshore (PGN) initiated with a Market Perform at Wells Fargo... Patterson-UTI Energy (PTEN) initiated with an Outperform at Wells Fargo... Pioneer Energy (PES) initiated with an Outperform at Wells Fargo... Realogy (RLGY) initiated with an Overweight at Piper Jaffray... Ruckus Wireless (RKUS) initiated with a Neutral at SunTrust... Sarepta (SRPT) initiated with an Outperform at Credit Suisse... Skyworks (SWKS) initiated with a Buy at MKM Partners... State Street (STT) initiated with a Buy at Citigroup... Ubiquiti Networks (UBNT) initiated with a Buy at SunTrust... Wafergen Biosystems (WGBS) initiated with a Buy at Brean Capital.
07:03 EDTSRPTSarepta initiated with an Outperform at Credit Suisse
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September 19, 2014
15:20 EDTSRPTSarepta sees start of large DMD trial delayed, Boston Business Journal reports
Sarepta CEO Chris Garabedian previously has said that dosing in a large confirmatory trial for its Duchenne muscular dystrophy drug eteplirsen would begin before the end of September, but he now sees dosing to begin in October or November due to delays “outside the company” with contract research and manufacturing partners, according to Boston Business Journal, citing an interview with the executive. Shares of Sarepta are down 4% in afternoon trading following the report. Reference Link
15:16 EDTSRPTSarepta CEO says start of main DMD trial delayed, Boston Business Journal says
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