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Stock Market & Financial Investment News

News Breaks
February 27, 2013
13:43 EDTGSK, SRPTDuchenne muscular dystrophy patients hospitalized, TheStreet says
Duchenne muscular dystrophy patients treated with drisapersen, GlaxoSmithKline's (GSK) experimental drug, have been hospitalized, according to a report by TheStreet that cites a Glaxo scientist speaking in Rome last Sunday. The report notes that Sarepta Therapeutics (SRPT) is meeting with the FDA this quarter to discuss the possibility of an accelerated approval filing for its Duchenne muscular dystrophy drug eteplirsen. Reference Link
News For GSK;SRPT From The Last 14 Days
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January 23, 2015
08:10 EDTGSKArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:44 EDTGSKGlaxo says now in position to deliver 'tens of thousands' of Ebola vaccine doses
Witty expects to start seeing data from trials of Ebola vaccines in next four to five months. GlaxoSmithKline CEO Andrew Witty speaking on CNBC.
06:39 EDTGSKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 22, 2015
16:15 EDTSRPTSarepta initiated with a Sector Perform at RBC Capital
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January 21, 2015
12:30 EDTGSKGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:01 EDTSRPTOn The Fly: Analyst Downgrade Summary
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06:59 EDTSRPTSarepta downgraded to Neutral from Outperform at Wedbush
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January 16, 2015
08:31 EDTGSKGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
15:26 EDTSRPTSarepta says no safety info or comparison in BioMarin presentation
Sarepta (SRPT) said that, given the small sample size of study 201/202, the company understood the importance of providing an "extensive amount of date" in order to understand eteplirsen's treatment effect. Sarepta has reported mITT data since week 24 and has continued to provide updates on this same mITT at every timepoint, the company said. BioMarin's (BMRN) presentation on Monday focused on extension phase and excluded dose-escalation phase and results during off-treatment periods, according to Sarepta. "Sarepta has regularly reported complete 201/202 safety data on all patients. No safety information or comparison [was included] in BioMarin's Monday presentation," Sarepta wrote in slides for its presentation at the JPMorgan Healthcare Conference.
14:31 EDTGSKMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
08:36 EDTGSKOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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07:13 EDTSRPTJPMorgan to hold a conference
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January 14, 2015
08:30 EDTSRPTSarepta says first patient dosed in European Phase 1/II SRP-4053 study
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January 12, 2015
16:32 EDTSRPTOn The Fly: Closing Wrap
Stocks spent almost the entire session in negative territory as the continued slump in crude oil prices weighed on equities. As the price of crude searches for a bottom, analysts and investors are concerned about how the low prices may affect U.S. economic growth. It had been estimated that more than half of the expected growth in the S&P 500's earnings would come from the oil industry and the continued drop in oil prices may be wiping out the chances of earnings increasing from the prior quarter. The earnings season unofficially kicks off tonight when Alcoa (AA) reports its fourth quarter earnings. ECONOMIC EVENTS: In the U.S., no major economic data was released. WTI and Brent crude both suffered slides of 5% during the session, sending WTI oil below $46 and Brent near $47 per barrel. Of note, Goldman Sachs said it sees oil prices bottoming in Q2 of this year at $42 a barrel. Goldman lowered its Brent crude oil price estimate for 2015 to $50 a barrel from $84 and for 2016 onwards to $70 a barrel from $90. COMPANY NEWS: Shire (SHPG) shares trading in New York slipped $8.39, or 3.86%, to $209.10 after the company announced over this weekend that it struck a deal to acquire NPS Pharmaceuticals (NPSP) for $46 per share in cash, for a total consideration of approximately $5.2B. NPS shares gained $3.44, or 8.21%, to $45.35... Shares of flash storage provider SanDisk (SNDK) dropped $13.47, or 13.88%, to $83.57 after the company cut its revenue outlook for Q4 and added that non-GAAP gross margin for the quarter is expected to be approximately 45%, compared to the previously guided range of 47%-49%. "The lower revenue was primarily due to weaker than expected sales of retail and iNAND products," SanDisk explained. Micron (MU) fell $1.87, or 5.56%, to $31.66 following the warning from its peer. MAJOR MOVERS: Among the notable gainers was Foundation Medicine (FMI), whose shares surged $22.81, or 95.32%, to $46.74 after the company and Roche (RHHBY) announced that they will enter into a strategic collaboration. Roche will invest in Foundation as part of the deal, resulting in Roche owning a minimum of 52.4% and a maximum of 56.3% of Foundation Medicine on a fully diluted basis. Also higher was Build-A-Bear Workshop (BBW), which jumped $3.12, or 16.75%, to $21.75 after the toy company gave a fourth quarter revenue view that beat expectations. Among the noteworthy losers was Arrowhead Research (ARWR), which fell $2.16, or 23.84%, to $6.90 after announcing that the FDA verbally informed the company of a partial clinical hold on its study of ARC-520 in patients with chronic hepatitis B infection. Also lower were shares of Sarepta Therapeutics (SRPT), which dropped $2.04, or 14.62%, to $11.91 after the company provided data through Week 168 from its Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy. INDEXES: The Dow fell 96.53, or 0.54%, to 17,640.84, the Nasdaq lost 39.36, or 0.84%, to 4,664.71, and the S&P 500 declined 16.55, or 0.81%, to 2,028.26.
12:04 EDTGSKNovartis sees closing GSK transactions in 1H15
Novartis (NVS) says portfolio transformation is progressing "on track." Sees closing GlaxoSmithKline (GSK) transactions in 1H. In 2015, plans to execute integration of GSK oncology business, execute separation of Vaccines, ensure successful start-up of Consumer Health JV with GSK. Sees NBS to continue to deliver synergies. Comments from slides that are being presented at the JP Morgan Healthcare Conference.
11:14 EDTSRPTDenver patient being tested for Ebola, KUSA-TV reports
A patient recently returned from Ebola affected areas in Africa is being tested in Denver for the disease, reported local NBC affiliate 9New KUSA-TV. Drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Some companies that offer protective clothing and waste disposal include Lakeland Industries (LAKE) and Alpha Pro Tech (APT). Reference Link
09:30 EDTSRPTOn The Fly: Pre-market Movers
HIGHER: Foundation Medicine (FMI) up 138.9% following transaction with Roche (RHHBY)... Celator Pharmaceuticals (CPXX), up 19.1% after announcing promising Phase 2 data for CPX-351... Second Sight (EYES), up 16.7% after Health Canada approves Argus II retinal prosthesis system... Aegerion (AEGR), up 7.8% after reporting preliminary fourth quarter results and guidance... Express (EXPR), up 4.5% after reporting preliminary fourth quarter results. NOTABLE: NPS Pharmaceuticals (NPSP), up 8.5% following acquisition by Shire (SHPG)... Shire is down 1.1% in pre-market trading. LOWER: Arrowhead (ARWR), down 20.9% after FDA clears company to begin modified study of ARC-520 in a preliminary call of a partial clinical hold... Tiffany (TIF), down 10.4% after lowering fiscal 2014 net EPS guidance... SanDisk (SNDK), down 10.1% after lowering fourth quarter outlook... Ascena Retail (ASNA), down 5.8% after lowering fiscal 2015 adjusted EPS view... Sarepta Therapeutics (SRPT), down 5.9% after reporting long-term outcomes from Phase IIb Eteplirsen study... Loral Space & Communications (LORL), down 3.6% following a NY Post article that reported that talks to sell itself to the Ontario Teachers’ Pension Plan have ended... Southwestern Energy (SWN), down 4.2% after filing to sell 20.3M shares of stock and 26M depository shares.
08:37 EDTGSKShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
07:10 EDTSRPTSarepta reports long-term outcomes from Phase IIb Eteplirsen study
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06:22 EDTGSKWHO approves 2 ebola vaccines to enter West Africa trials, Financial Times says
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