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News Breaks
July 22, 2014
10:00 EDTSRPT, PTCT, ENPH, WPG, QSII, NEP, CSG, TSE, QIWI, MTX, ZPIN, ATNM, ABY, AXYSOn 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.
News For ABY;ATNM;AXYS;CSG;ENPH;MTX;NEP;PTCT;QIWI;QSII;SRPT;TSE;WPG;ZPIN From The Last 14 Days
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August 26, 2015
09:09 EDTSRPTSarepta upgraded to Outperform from Sector Perform at RBC Capital
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09:03 EDTENPHEnphase Energy selected by Vision Solar as preferred inverter supplier
Enphase Energy has been selected as the preferred inverter supplier and module-level power electronics partner for Vision Solar via its distribution arrangement with electrical distributor, Gexpro. Fueled by 400% year-on-year growth, Vision Solar is one of the nation's fastest growing, full-service residential solar installers, with operations in California, Nevada, Utah, Texas, New Jersey, and South Carolina. Vision Solar cited Enphase's simplicity of design and installation, quality and reliability of its equipment, 25-year warranty, and comprehensive services as some of the compelling reasons behind the installer's decision to replace its existing MLPE supplier.
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.
16:48 EDTNEPNextEra Energy Partners initiated with an Outperform at Baird
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09:59 EDTPTCTOn The Fly: Analyst Initiation Summary
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08:01 EDTPTCTPTC Therapeutics initiated with a Buy at Citi
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August 24, 2015
17:01 EDTENPHEnphase Energy signs strategic partnership with Solar Partners New Zealand
Enphase Energy announced it has entered into a distribution agreement with Solar Partners New Zealand. Solar Partners New Zealand will distribute the world-leading Enphase Solar Energy System to key installers across the country. The Solar Partners New Zealand partnership falls in line with Enphase's aggressive growth following the company's recent opening of a second Australian office in Sydney, whilst undergoing a substantial expansion of its New Zealand Engineering Office.
15:44 EDTPTCTOptions with increasing implied volatility
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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.
10:12 EDTPTCTOptions with increasing implied volatility
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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 EDTSRPT, PTCTOptions 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
09:57 EDTABYAbengoa Yield management to meet with Canaccord
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August 19, 2015
09:17 EDTSRPT, PTCT'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 EDTSRPT, PTCTFlibanserin approval bodes well for Sarepta, others, says Roth Capital
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