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Stock Market & Financial Investment News

News Breaks
April 16, 2013
10:20 EDTSRPTSarepta tumbles after FDA requests more data on drug
Shares of Sarepta Therapeutics (SRPT) are sinking after the company announced that the FDA had requested additional information about its eteplirsen treatment for Duchenne muscular dystrophy, or DMD. WHAT'S NEW: The FDA requested that Sarepta provide a summary explaining why dystrophin, the production of which is supposed to be stimulated by eteplirsen, is an acceptable therapy for DMD, Sarepta announced last night. The FDA also requested detailed information about the clinical trials of eteplirsen, and indicated that it would need the information in order to help determine whether the drug is eligible for accelerated approval, according to Sarepta. The company said that it was "encouraged" by its discussions with the FDA. ANALYST REACTION: In a note to clients, Piper Jaffray analyst Edward Tenthoff wrote that the FDA's request indicates that the agency is looking to find a way to grant the drug accelerated approval. There is now a greater than 50/50 chance that Sarepta will be able to file for approval of the drug based on existing data, the analyst believes, adding that such a development should cause the stock to advance significantly. If, on the other hand, Sarepta is required to conduct a Phase III clinical trial of the drug before obtaining FDA approval for it, the resulting drop in the stock will create a buying opportunity, added Tenthoff. The analyst increased his price target on the shares to $50 from $35 and reiterated an Overweight rating on the stock. TODAY'S PRICE ACTION: In mid-morning trading, Sarepta fell $5.65, or 14.4%, to $33.50.
News For SRPT From The Last 14 Days
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October 19, 2014
13:39 EDTSRPTCarnival cruise passenger tests negative for Ebola, Reuters says
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October 17, 2014
14:50 EDTSRPTBARDA asks labs to ramp up Zmapp production, Reuters says
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09:46 EDTSRPTSarepta soars after publication of Ebola drug candidate data
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09:17 EDTSRPTOn The Fly: Pre-market Movers
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October 16, 2014
18:36 EDTSRPTOn The Fly: After Hours Movers
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18:16 EDTSRPTSarepta up 10.6% following publication of Ebola phase 1 clinical study
16:13 EDTSRPTSarepta announces publication of Ebola, Marburg Phase I clinical study results
Sarepta Therapeutics announced the publication of results from two single ascending-dose studies that demonstrated no clinical or toxicologic safety concerns with the company’s drug candidates for the treatment of Ebola and Marburg virus, respectively. AVI-6002 for the treatment of Ebola is a combination therapy of two phosphorodiamidate morpholino oligomers, which target the viral matrix proteins VP24 and VP35, respectively. AVI-6003 for the treatment of Marburg is a combination therapy of two PMOs, which target the viral proteins VP24 and NP, respectively. These drug candidates use Sarepta’s advanced and proprietary PMOplus chemistry, which is also the basis of the company’s clinical-stage influenza drug candidate, AVI-7100. Results from previous viral challenge studies of AVI-6002 and AVI-6003 in non-human primates demonstrated prevention of disease development and death following exposure to Ebola or Marburg virus. Subsequent animal studies demonstrated that for each combination therapy, only one oligomer contributed to efficacy, and therefore, the lead drug candidates for Ebola and Marburg have since become the single compounds AVI-7537 and AVI-7288.
October 15, 2014
10:49 EDTSRPTEbola linked names rise again amid broader market sell-off
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October 14, 2014
09:04 EDTSRPTChinese company says drug can cure Ebola, Reuters reports
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October 13, 2014
12:44 EDTSRPTSarepta data supported by DMD study in journal, TheStreet reports
A study published in medical journal PLOS One following the progression of Duchenne muscular dystrophy supports Sarepta's push for accelerated approval of eteplirsen, TheStreet's Adam Feuerstein reports. Reference Link
October 12, 2014
19:26 EDTSRPTPatient being evaluated at Boston hospital for possible Ebola, Boston Globe says
Health officials say that a man that recently traveled to Liberia is being assessed at Beth Israel Deaconess hospital in Boston for the Ebola virus, the Boston Globe says. Drug companies that are working on experimental Ebola treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Reference Link
19:12 EDTSRPTCDC confirms Texas healthcare worker positive for Ebola
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14:18 EDTSRPTNY's JFK Airport begins Ebola screenings, WSJ says
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12:48 EDTSRPTTexas health-care worker tests positive for Ebola, WSJ says
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October 10, 2014
10:54 EDTSRPTMapp looking to up production of experimental Ebola treatment, WSJ says
Mapp Biopharmaceutical is aiming to broaden the manufacturing of its experimental Ebola treatment, ZMapp, according to The Wall Street Journal, citing comments from the company. Mapp said that the treatment was given to a few infected individuals prior to supplies running out two months ago. Drug companies that are working on experimental Ebola treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Reference Link
October 9, 2014
14:55 EDTSRPTHospital says deputy showing no signs of Ebola, AP reports
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14:24 EDTSRPTCDC head compares Ebola to AIDS, Washington Post says
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14:13 EDTSRPTFirst Ebola vaccine trial in West Africa started, NBC News reports
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12:06 EDTSRPTLakeland Industries continues surge amid Ebola fears
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October 8, 2014
11:22 EDTSRPTChimerix falls after Ebola patient taking experimental drug dies
Shares of Chimerix (CMRX) are moving lower after the Texas Health Presbyterian Hospital Dallas announced that Thomas Eric Duncan succumbed to Ebola. Duncan was being treated with Chimerix's experimental drug Brincidofovir. Shares of Chimerix dropped 9% following the news to $30.19. Other makers of experimental Ebola treatments include Tekmira (TKMR), Sarepta (SRPT) and BioCryst (BCRX).
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