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February 10, 2014
08:31 EDTSRPTSarepta reports results from Phase 1 study of Marburg drug candidate
Sarepta Therapeutics announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers. AVI-7288, which uses Sarepta’s advanced and proprietary PMOplus chemistry, is the company’s lead drug candidate for the treatment of Marburg virus infection. Sarepta has been developing AVI-7288 under a Department of Defense contract managed by the Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. The Phase I clinical study was a randomized, double-blind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing. In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days. Results showed that AVI-7288 was well tolerated through the highest dose tested, 16 mg/kg per day, which is higher than the anticipated therapeutic dose, with no reported serious or clinically significant adverse events. An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288.
News For SRPT From The Last 14 Days
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July 30, 2014
09:16 EDTSRPTSarepta up 12% to $22.70 after FDA responds to DMD drug petition
09:14 EDTSRPTFDA letter bodes well for Sarepta DMD filing, says Deutsche Bank
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09:04 EDTSRPTFDA says 'willing to explore' accelerated approval for DMD drugs
In response to a White House petition urging the FDA to accelerate approval for safe, effective therapies for children with Duchenne, Janet Woodcock, Director, FDA Center for Drug Evaluation and Research, said in a response, "We are willing to explore the use of all potential pathways for the approval of drugs for Duchenne muscular dystrophy, including accelerated approval, as appropriate." She added, "We share your sense of urgency to make safe and effective drugs available for patients with Duchenne muscular dystrophy as soon as possible. That's why we're actively engaged with a number of drug companies focused on developing new drugs for Duchenne muscular dystrophy, including Sarepta Therapeutics, the company developing eteplirsen, an investigational new drug for Duchenne muscular dystrophy." Shares of Sarepta (SRPT) are trading up 5%, or 97c, to $21.30 in pre-market trading. Yesterday afternoon, Wall Street Journal reported that Sarepta is limiting the role its CEO Chris Garabedian is playing in talks with the FDA. Prosensa (RNA) is also developing a treatment for Duchenne muscular dystroph, or DMD. Reference Link
July 29, 2014
15:26 EDTSRPTSarepta CEO role in talks with FDA on eteplirsen to be limited, WSJ says
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July 25, 2014
09:57 EDTSRPTSarepta CSO had 'serious disagreements' with CEO, WSJ reports
Sarepta's recently terminated Chief Scientific Officer Arthur Krieg said he had "serious disagreements" with CEO Chris Garabedian, Wall Street Journal reported last night, citing comments from a phone interview. Krieg's termination follows other management departures and "interrupts" the process" of preparing eteplirsen paperwork for the FDA, the Journal added, citing a person familiar with the matter. Recall that The Street's Adam Feuerstein reported yesterday that Krieg had no role in the clinical development of eteplirsen. Reference Link
July 24, 2014
09:37 EDTSRPTSarepta fired CSO not involved in eteplirsen, The Street reports
Sarepta's just fired Chief Scientific Officer Art Krieg had no role in the clinical development of eteplirsen, The Street's Adam Feuerstein reports, citing two sources familiar with the situation. Krieg's exit relates to Sarepta being behind schedule in bringing new drugs into the clinic, Feuerstein adds. Reference Link
09:16 EDTSRPTOn The Fly: Pre-market Movers
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06:52 EDTSRPTSarepta terminates Chief Scientific Officer Arthur Krieg
Sarepta disclosed that on July 22, Arthur Krieg, M.D., the company's Chief Scientific Officer, was terminated from his position. No other information was provided in the regulatory filing disclosing the news.
July 22, 2014
10:00 EDTSRPTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Abengoa Yield (ABY) initiated with an Equal Weight at Morgan Stanley... Actinium Pharmaceuticals (ATNM) initiated with a Buy at Canaccord... Axys Technologies (AXYS) initiated with a Buy at Dougherty... Chambers Street Properties (CSG) initiated with a Neutral at SunTrust... Enphase Energy (ENPH) initiated with a Buy at Dougherty... Minerals Technologies (MTX) initiated with an Outperform at Wedbush... NextEra Energy Partners (NEP) initiated with a Buy at BofA/Merrill... PTC Therapeutics (PTCT) initiated with a Buy at BofA/Merrill... QIWI (QIWI) initiated with a Positive at Susquehanna... Quality Systems (QSII) initiated with a Buy at Topeka... Sarepta (SRPT) initiated with a Neutral at BofA/Merrill... Trinseo S.A. (TSE) initiated with a Buy at BofA/Merrill... Washington Prime Group (WPG) initiated with a Neutral at SunTrust... Zhaopin (ZPIN) initiated with a Buy at UBS.
07:11 EDTSRPTSarepta initiated with a Neutral at BofA/Merrill
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