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Stock Market & Financial Investment News

News Breaks
August 1, 2014
10:00 EDTSCMP, RNA, PTCT, CBAY, SRPT, BIN, FLML, CWST, SGMO, PZG, FINL, ANETOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Arista Networks (ANET) initiated with a Neutral at Citigroup... Casella Waste (CWST) initiated with a Hold at Stifel... CymaBay Therapeutics (CBAY) initiated with an Outperform at Cowen... Finish Line (FINL) initiated with a Buy at Jefferies... Flamel Technologies (FLML) initiated with an Outperform at Leerink... PTC Therapeutics (PTCT) initiated with an Outperform at Oppenheimer... Paramount Gold & Silver (PZG) initiated with a Buy at Noble Financial... Progressive Waste (BIN) initiated with a Hold at Stifel... Prosensa (RNA) initiated with an Outperform at Oppenheimer... Sangamo (SGMO) initiated with an Overweight at JPMorgan... Sarepta (SRPT) initiated with an Outperform at Oppenheimer... Sucampo (SCMP) initiated with a Buy at Roth Capital.
News For ANET;CWST;CBAY;FINL;FLML;PTCT;PZG;BIN;RNA;SGMO;SRPT;SCMP From The Last 14 Days
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August 26, 2015
07:47 EDTSCMPSucampo to host conference call
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06:19 EDTSCMPSucampo launches tender offer to acquire R-Tech Ueno for $278M
Sucampo Pharmaceuticals announced the launch of an all-cash tender offer in Japan by Sucampo's Japanese subsidiary and the execution of a separate share purchase agreement with certain shareholders of R-Tech Ueno to acquire all outstanding shares of R-Tech Ueno for a total consideration of JPY33 billion, or approximately $278M, inclusive of approximately $54M in cash and 2.5M Sucampo shares, held by R-Tech Ueno. The purchase price reflects a 16% premium over R-Tech Ueno's one-month volume weighted average price and a 16% premium over R-Tech Ueno's three-month volume weighted average price. Assuming a successful completion of the acquisition, for full year 2016, excluding amortization and debt costs related to the proposed transaction, Sucampo expects to achieve net income of $55M to $60M , earnings per share of $1.20 to $1.30, and adjusted EBITDA of $95M to $100M. In addition, Sucampo expects to achieve pre-tax operational synergies of approximately $5M on an annualized basis in 2016. Sucampo does not expect the acquisition to have a material impact on 2015 results given the expected timing of transaction close. R-Tech Ueno is a Japanese pharmaceutical company that manufactures AMITIZA for Sucampo and Sucampo's commercialization partners, Takeda Pharmaceuticals, Mylan N.V. and Harbin Gloria Pharmaceuticals. R-Tech Ueno also receives revenue from sales of RESCULA in Japan. In addition, the company has a diverse pipeline of drug candidates in various stages of development in gastroenterology, ophthalmology, autoimmune and inflammatory diseases, and oncology. In the tender offer, which has been unanimously approved by the Board of Directors of both companies, Sucampo's Japanese subsidiary Sucampo Pharma, LLC will offer JPY1,900 per share in cash for the shares of R-Tech Ueno. Sucampo is expecting to acquire 56% of the outstanding shares of R-Tech Ueno in the tender offer. Separately, Sucampo has entered into agreement with R-Tech Ueno's founders and a related entity to acquire the remaining 44% of R-Tech Ueno shares for JPY1,400 per share; the closing of this share purchase is conditioned on the closing of the tender offer. The tender offer period is expected to end on October 13, 2015, assuming the tender offer achieves the minimum acceptance threshold, regulatory approvals and other customary conditions, subject to our right to extend the offer. Following completion of the tender offer and the closing of the share purchase agreement with the founders, Sucampo will acquire all remaining outstanding shares of R-Tech Ueno not acquired through the tender offer through a squeeze-out process. The squeeze out process may take up to 13 weeks to complete. The aggregate acquisition price of R-Tech Ueno will be approximately $278 million. Sucampo expects to close the acquisition in the fourth quarter of 2015.
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.
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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06:03 EDTPZGParamount Gold and Silver defines seven targets around Sleeper Mine
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August 24, 2015
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 EDTSCMPOn The Fly: Analyst Initiation Summary
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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.
07:29 EDTSCMPSucampo initiated with a Buy at H.C. Wainwright
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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
14:39 EDTANETEarnings Watch: Hewlett-Packard reports ahead of company split
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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, 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 EDTPTCT, SRPTFlibanserin approval bodes well for Sarepta, others, says Roth Capital
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