New User:

-or-
Username:
Password:
Forgot your password?

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
Sign up for a free trial to see the rest of the stories you've been missing.
September 30, 2014
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
Subscribe for More Information
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
Subscribe for More Information
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
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use