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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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February 8, 2016
12:05 EDTSRPTOn The Fly: Top stock stories at midday
Stocks on Wall Street began the session deep in negative territory and proceeded to move lower throughout the session, amid a renewed selloff in oil prices and fears that bankruptcies related to the prolonged slump will begin to pick up pace. The move lower is not restricted to the energy sector and has been broad-based, as each of the major equity indexes was lower by about 2% or more. ECONOMIC EVENTS: In the U.S., the labor market conditions index came in at 0.4 for January, below expectations for a reading of 2.0. In Asia, markets in mainland China, Hong Kong, Taiwan and Korea were all closed for the New Year holiday. Data was still released in China that showed the country's foreign currency reserves fell to their lowest level since May 2012, dropping about $99B in January, though that was better than analysts forecast and ahead of some recent whispers. COMPANY NEWS: Chesapeake Energy (CHK) tumbled over 50%, dropping as low as $1.50 per share, after media reports indicated that the natural gas producer has hired restructuring lawyers from Kirkland & Ellis. Subsequently, the stock was halted pending news and the company confirmed that Kirkland & Ellis continues to advise the company as it seeks to further strengthen its balance sheet. However, Chesapeake noted that it currently has "no plans to pursue bankruptcy," and its shares recovered some of their earlier losses upon being reopened for trading. The stock was down a bit over 25% near noon... Meanwhile, another player in the oil space with ties to Chesapeake, Energy Transfer Equity (ETE), declined 30% after the company disclosed, via a regulatory filing after Friday's close, that it was making a change to the Chief Financial Officer of its general partner. According to the company, the departure of CFO Jamie Welch from the post was not caused by any disagreements between him and the MLP over accounting issues or financial matters. Williams Company (WMB), with has agreed to merge with Energy Transfer, also slid 25%. MAJOR MOVERS: Among the notable gainers was Apollo Education (APOL), which rallied 25% after it agreed to be acquired by a group led by private equity company Apollo Global (APO) for $9.50 per share. Also higher was GoPro (GPRO), which gained 9% after Microsoft (MSFT) announced a new collaborative patent licensing agreement with the beaten down action camera maker. Among the noteworthy losers was Sarepta (SRPT), which fell 12% after the FDA delayed a decision on the company's Duchenne muscular dystrophy treatment eteplirsen. Also lower was BioCryst (BCRX), which plunged 67% after a clinical trial of its hereditary angioedema drug failed to meet its primary endpoint. In addition, DexCom (DXCM) was 17% lower after it was downgraded to Neutral from Outperform at Baird. INDEXES: Near midday, the Dow was down 317.14, or 1.96%, to 15,887.83, the Nasdaq was down 101.02, or 2.32%, to 4,262.12, and the S&P 500 was down 36.43, or 1.94%, to 1,843.62.
10:17 EDTSRPTSarepta approval seen as 'long shot' as FDA pushes back decision
Shares of drugmaker Sarepta Therapeutics (SRPT) took a dive in morning trading after the company said the U.S. Food and Drug Administration delayed a decision on eteplirsen for the treatment of Duchenne muscular dystrophy. WHAT'S NEW: Sarepta announced that the FDA has pushed out the the Prescription Drug User Fee Act, or PDUFA, date for eteplirsen for the treatment of Duchenne muscular dystrophy to May 26. The previous PDUFA date for the eteplirsen new drug application, or NDA, was originally set for late February. FDA POSTPONEMENT: The FDA notified Sarepta that it's submission of 4-year clinical data, including additional six minute walk test and loss of ambulation data compared to historical control, was designated as a "major amendment" to the NDA and that the PDUFA goal date was extended to allow for a full review of the submission. The FDA previously granted eteplirsen Priority Review status, as well as Rare Pediatric Disease Designation, Orphan Drug Designation and Fast Track Status to eteplirsen. WHAT'S NOTABLE: In late January, the FDA postponed a meeting of its advisory committee to review the Sarepta drug due to an inclement weather forecast for Washington D.C. LONG SHOT: Piper Jaffray analyst Edward Tenthoff told investors in a note that the FDA's PDUFA date postponement for eteplirsen is "not surprising" following the delay of the January 22 AdCom due to weather. Tenthoff also noted that a new AdCom has yet to be scheduled. The analyst continues to see eteplirsen accelerated approval by the new PDUFA date as a "long shot." He believes that the panel discussion will be a "plea from the community" to approve something for DMD and that members will not be asked to vote on drug approval. Tenthoff has a Neutral rating and $15 price target on Sarepta. OTHERS TO WATCH: Other companies developing treatments for Duchenne muscular dystrophy include BioMarin (BMRN) and PTC Therapeutics (PTCT). PRICE ACTION: Sarepta is down 9.5% in morning trading to $11.06.
09:22 EDTSRPTSarepta accelerated approval by new PDUFA a 'long shot,' says Piper
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08:32 EDTSRPTSarepta receives notification of PDUFA extension for eteplirsen to May 26
Sarepta Therapeutics announced that the U.S. FDA will require additional time to complete its review of the New Drug Applicationfor eteplirsen, for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping. In a notice received from the FDA, the Prescription Drug User Fee Act date for eteplirsen has been extended to May 26, 2016. The rescheduled date for the Peripheral and Central Nervous System Advisory Committee meeting has not yet been determined. The FDA notified Sarepta that its January 8, 2016 submission of 4-year clinical effectiveness data, which included additional six minute walk test and loss of ambulation data compared to a historical control, has been designated as a major amendment to the NDA. The FDA stated that the PDUFA goal date has been extended by three months to allow for a full review of the submission. As described in the Sarepta Advisory Committee Briefing Document Addendum, the principal basis for establishing the effectiveness of eteplirsen is a comparison of patients in Study 201/202 to a historical control group. The FDA has previously granted eteplirsen Priority Review status, which is designated for drugs that provide a treatment where no adequate therapy exists. The FDA also granted Rare Pediatric Disease Designation to eteplirsen, as well Orphan Drug Designation and Fast Track Status.
January 26, 2016
10:06 EDTSRPTOptions with decreasing implied volatility
Options with decreasing implied volatility: SRPT GNC ALKS CALM NFLX CREE FFIV COH ISRG IBM
January 25, 2016
10:22 EDTSRPTOptions with decreasing implied volatility
Options with decreasing implied volatility: SRPT SPWR NFLX CREE FFIV ISRG TIF MXIM QIHU IBM

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