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News Breaks
July 10, 2014
11:50 EDTSRPTSarepta story correction issued by Wall Street Journal
The Wall Street Journal reported that its prior story, entitled "Sarepta to Submit Study on Muscular Dystrophy Drug to FDA Later Than Expected," at 9:12 a.m. EDT incorrectly suggested the decision to delay the application was unveiled Thursday. The Journal noted in its correction that the delay was previously reported. Reference Link
News For SRPT From The Last 14 Days
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August 27, 2015
12:57 EDTSRPTFDA will approve Sarepta and BioMarin DMD drugs, Feuerstein says
TheStreet's biotech reporter Adam Feuerstein predicts that the FDA will approve both Biomarin's (BMRN) drisapersen and Sarepta's (SRPT) eteplirsen, which are both drugs to treat Duchenne muscular dystrophy, adding that the agency has been "essentially approving every drug that comes before it" and that it "can't and won't" say no to two drugs meant to improve the lives of kids with a fatal disease. Feuerstein noted he doesn't think the drugs are equivalent and he's still in the "eteplirsen is better than drisapersen" camp. Reference Link
August 26, 2015
13:38 EDTSRPTSarepta rises after FDA accepts muscular dystrophy drug application
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10:00 EDTSRPTOn The Fly: Analyst Upgrade Summary
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09:19 EDTSRPTSarepta upgraded at RBC Capital on expectations for eteplirsen approval
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09:09 EDTSRPTSarepta upgraded to Outperform from Sector Perform at RBC Capital
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09:02 EDTSRPTSarepta should be bought on any weakness, says Roth Capital
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August 25, 2015
18:47 EDTSRPTOn The Fly: After Hours Movers
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17:19 EDTSRPTFDA files NDA for Sarepta's eteplirsen
Sarepta Therapeutics announced that the FDA has filed the New Drug Application, or NDA, for eteplirsen for the treatment of Duchenne muscular dystrophy, or DMD, amenable to exon 51 skipping. Approximately 13% of people with Duchenne muscular dystrophy are estimated to have a mutation addressable by Eteplirsen/exon 51 skipping. The FDA has completed its filing review and has determined that our application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act action date for a decision on the application is February 26. The FDA has granted eteplirsen Priority Review status, which is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists.
August 24, 2015
13:54 EDTSRPTFly Watch: Sarepta upgraded ahead of FDA deadline on DMD drug
The 60-day FDA review period for Sarepta's (SRPT) rolling NDA submission for its Duchenne muscular dystrophy drug eteplirsen ends tomorrow, Tuesday, August 25. Piper Jaffray is among research firms taking a bullish stance on the stock ahead of tomorrow's deadline. BACKGROUND: Eteplirsen is an "exon skipping" treatment that attempts to bypass genetic mutations to allow improved functioning of the affected gene. On August 21, Sarepta announced that the FDA granted a rare pediatric disease designation for eteplirsen, in addition to its previous orphan designation and fast track status. Piper Jaffray's Edward Tenthoff noted today that the drug could see a February 2016 PDUFA date, potentially yielding "blockbuster sales" for the company. Importantly, BioMarin's (BMRN) drisapersen is slightly ahead of eteplirsen's approval process with a December 27 PDUFA date, posing a potential competitive risk for Sarepta. PDUFA dates are FDA deadlines for approving new drugs, normally coming within 6 or 10 months of an NDA acceptance depending on the drug's priority status. ANALYST TAKE: Tenthoff stated in note to investors this morning that he expects the Food and Drug Administration to accept the New Drug Application for Sarepta's eteplirsen at the end of its 60-day review period tomorrow. Additionally, Tenthoff sees a joint advisory committee for eteplirsen and the similar drisapersen from BioMarin on November 23-24. On May 19, Sarepta said it held pre-NDA meetings with the FDA, and Piper Jaffray said it believes the company has now met all of the agency's information requests. The analyst upgraded Sarepta to Overweight from Neutral and hiked his price target to $48 from $28 and now values eteplirsen at $1.3B, up from $919M previously. PRICE ACTION: Shares of Sarepta Therapeutics are up roughly 1% in intraday trading to $34.21. The stock jumped about 60% on May 20 after the company announced its mid-year NDA plans for eteplirsen. BioMarin shares, meanwhile, are down 2% to $123.59 this afternoon.
09:45 EDTSRPTOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Bank of America (BAC) upgraded to Outperform from Market Perform at Keefe Bruyette... Bristol-Myers (BMY) upgraded to Neutral from Underweight at Piper Jaffray... Chevron (CVX) upgraded to Neutral from Underperform at BofA/Merrill... Abercrombie & Fitch (ANF) upgraded to Overweight from Neutral... Nike (NKE) upgraded to Outperform from Market Perform at Telsey Advisory... DreamWorks (DWA) upgraded to Buy from Neutral at B. Riley... Caesarstone (CSTE) upgraded to Overweight from Equal Weight at Barclays... TransAlta (TAC) upgraded to Outperform from Market Perform at BMO Capital... Sarepta (SRPT) upgraded to Overweight from Neutral at Piper Jaffray... AutoZone (AZO) upgraded to Buy from Neutral at BofA/Merrill... Royal Dutch Shell (RDS.A) upgraded to Buy from Hold at Jefferies... Allscripts (MDRX) upgraded to Buy from Hold at Argus... China Unicom (CHU) upgraded to Buy from Hold at Jefferies... Ross Stores (ROST) upgraded to Buy from Neutral at Buckingham.
06:50 EDTSRPTSarepta upgraded to Overweight from Neutral at Piper Jaffray
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August 21, 2015
10:36 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: PTCT UVXY VIX VXX SVXXY SRPT TZA UPRO VNR SPXU
08:32 EDTSRPTSarepta says FDA grants rare pediatric disease designation for Eteplirsen
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August 20, 2015
11:49 EDTSRPTOptions with increasing implied volatility
Options with increasing implied volatility: SRPT ACHN VIAV ZG RAD DIS ORCL SPY XLF OEX
August 19, 2015
09:17 EDTSRPT'Female Viagra' approval seen as positive for Sarepta, BioMarin
The FDA's approval of the world's first drug designed to boost a woman's sexual desire is seen as boding well for companies awaiting critical decisions by the agency. FEMALE VIAGRA: The Food and Drug Administration yesterday approved flibanserin to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. The drug, which will be sold under the name "Addyi" and is commonly referred to as the "female Viagra," is the first FDA-approved treatment for sexual desire disorders in men or women, the agency prominently stated in its press release. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance, the FDA explained. Addyi was approved with a risk evaluation and mitigation strategy as well as a Boxed Warning given the risk of severe hypotension and syncope in patients who drink alcohol during treatment. The drug is made by privately held Sprout Pharmaceuticals. ANALYST REACTION: Addyi's approval is "another sign of flexibility" by the FDA, especially for first-in-class therapies, Roth Capital analyst Debjit Chattopadhyay writes this morning in a note to investors. This bodes well for the approval of eteplirsen, drisapersen and Translarna, the analyst contends. Eteplirsen, designed by Sarepta Therapeutics (SRPT), and drisapersen, designed by BioMarin (BMRN), are experimental drugs being developed to treat Duchenne muscular dystrophy. Translarna, designed by PTC Therapeutics (PTCT), is already being sold in Europe as a treatment for DMD and is awaiting approval from the FDA. Duchenne muscular dystrophy is a form of muscular dystrophy affecting around 1 in 3,600 boys, which results in muscle degeneration and premature death. SAVING LIVES: While female sexual dysfunction is a clinical problem, eteplirsen is designed to save lives, Chattopadhyay points out. He has a Buy rating on Sarepta and noted his price target of $45 assumes accelerated approval for eteplirsen in the first quarter of 2016. Shares of the Massachusetts-based biopharmaceutical company closed yesterday at $35.69.
08:29 EDTSRPTFlibanserin approval bodes well for Sarepta, others, says Roth Capital
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August 17, 2015
06:22 EDTSRPTPiper's Tenthoff sees select biotech names outperforming in second half
Piper Jaffray analyst Edward Tenthoff expects drug launches, clinical data read-outs and potential partnerships to drive outperformance for select biotech names in the second half of 2015. Despite some recent profit-taking, 2015 has been another strong year for biotech stocks, Tenthoff tells investors in a research note. Names with important second half of the year catalysts include Vertex (VRTX), Regeneron (REGN), Seattle Genetics (SGEN), Exelixis (EXEL), Sarepta (SRPT), Novavax (NVAX), Arrowhead (ARWR), Array BioPharma (ARRY), Alnylam (ALNY), Genocea (GNCA), CymaBay (CBAY), Idera Pharmaceuticals (IDRA), Vitae Pharmaceuticals (VTAE).

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