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News Breaks
May 22, 2014
08:32 EDTSRPTSarepta announces acquisition of Massachusetts manufacturing facillity
Sarepta Therapeutics announced an agreement to acquire a multifunctional manufacturing facility on 26 acres of land in Massachusetts. Sarepta intends to use the facility to manufacture investigational exon skipping therapies for Duchenne muscular dystrophy. The transaction comprises approximately $25M in acquisition costs and planned enhancements, and is expected to close in July subject to conditions and extensions in the agreement.
News For SRPT From The Last 14 Days
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April 1, 2015
15:18 EDTSRPTSarepta launch may see modest delay if FDA wants more work, says Credit Suisse
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10:04 EDTSRPTHigh option volume stocks
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09:23 EDTSRPTOn The Fly: Pre-market Movers
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09:13 EDTSRPTSarepta surges as analysts see CEO change helping FDA interactions
Shares of biopharmaceutical company Sarepta Therapeutics (SRPT) are surging in pre-market trading after the company announced the resignation of its president and Chief Executive Officer. WHAT'S NEW: Sarepta, which has drugs in development for Duchenne muscular dystrophy and infectious diseases like Ebola, said late last night that Christopher Garabedian has resigned as president, CEO and as a member of the board, effective immediately. Chief Medical Officer Edward Kaye has been appointed as the company's interim CEO, also effective immediately. Kaye will continue to serve as CMO in addition to his interim CEO role as the company seeks a new full-time CEO, and will focus his efforts on heading the regulatory process for eteplirsen, the company's lead product candidate, as well as follow on "exon" drug candidates for DMD. Kaye commented that the company is on track in collecting and analyzing data that has been requested by the Food and Drug Administration that is necessary for the company to submit the new drug application for eteplirsen in mid-2015 as planned. WHAT'S NOTABLE: On the company's conference call discussing Kaye's appointment, Kaye commented that decision to replace Garabedian as CEO had "nothing to do" with the data for eteplirsen and that it was "between the board and Chris." Kaye said that the company will meet in the second quarter with the FDA and if there are any changes in the company's planned mid-year submission, Sarepta "certainly" will let people be aware of that. Kaye said the company is still collecting the safety information and that it will be submitted to the FDA, but noted that the company has not had any changes to date in its safety profile for eteplirsen. ANALYST REACTION: RBC Capital thinks that a change at the CEO position could enhance the company's interactions with the FDA and increase its credibility with investors, noting that Garabedian's interactions had previously drawn investor criticism. The firm, which has a Market Perform rating on Sarepta, ultimately thinks the determining factor for the stock will be the eteplirsen data and how the FDA views it. SunTrust, which has a Neutral rating on the stock, says it is "very pleased" by Kaye's promotion, as he has always been "a stabilizing force" at Sarepta. The firm also noted that Kaye's experience in developing orphan drugs has always been "well-appreciated" by the Street. Roth Capital this morning noted the "strained" relationship between the FDA and Sarepta under Garabedian's leadership, including the "mutual animosity and distrust" between the two. The firm believes the management transition is aimed at normalizing relations with the FDA. ANOTHER TO WATCH: Prosensa, which has been acquired by Biomarin (BMRN), is also at work on Duchenne muscular dystrophy treatments. PRICE ACTION: Sarepta shares jumped 8% to $14.35 in pre-market trading after the announcement of the leadership change.
08:55 EDTSRPTSarepta interim CEO says no changes to date in safety profile for eteplirsen
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08:36 EDTSRPTSarepta interim CEO says meeing with FDA still planned for Q2
Sarepta Therapeutics interim CEO Edward Kaye said the company will be having a meeting in the second quarter with the FDA and "obviously what we're focusing on is the discussion about the data, the robustness of the package and making sure they're in agreement." If there is any changes in the company's planned mid-year submission, the company "certainly" will let people be aware of that, Kaye added.
08:28 EDTSRPTSarepta says process for submitting eteplirsen NDA on track
Sarepta Therapeutics interim CEO Edward Kaye said on the company's call regarding his appointment to the post that the company remains "on track" in collecting and analyzing the data requested by the FDA for Sarepta to submit the New Drug Application for eteplirsen in the middle of this year as planned. Kaye also said in response to a question about why Christopher Garabedian was replaced as CEO the decision was "between the Board and Chris" and has "nothing to do" with the eteplirsen data itself.
08:16 EDTSRPTSarepta interim CEO a good choice, says SunTrust
After Sarepta (SRPT) announced that its CEO had resigned and would be replaced on an interim basis by Chief Medical Officer Ed Kaye, SunTrust says it is "very pleased" by Kaye's promotion. Kaye has always been "a stabilizing force" at Sarepta, while his experience in developing orphan drugs has always been well-appreciated by the Street and he is "the ideal chaperon" for Sarepta's eteplirsen drug, the firm stated. However, SunTrust keeps a Neutral rating on the shares.
07:13 EDTSRPTSarepta CEO change positive, says RBC Capital
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06:50 EDTSRPTSarepta to host business news update conference call
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05:09 EDTSRPTSarepta appoints Edward Kaye, M.D., as Interim CEO
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March 30, 2015
14:47 EDTSRPTDMD drug panelist confirms conflict of interest, Boston Business Journal says
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