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
Check below for free stories on SRPT the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
July 30, 2014
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
Subscribe for More Information
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
Subscribe for More Information
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
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