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News Breaks
August 25, 2014
12:19 EDTCELG, ANN, SNY, ITMN, GILD, LTM, RGDO, THI, QIHU, GSK, RHHBY, BKWOn The Fly: Midday Wrap
Stocks on Wall Street continued their recent run higher, pushing the S&P 500 above 2,000 for the first time ever. The benchmark index hit the record level despite a report that showed new home sales unexpectedly declined in July. At the lunch hour, the averages were just off their best levels and the S&P had dipped back just below the 2K milestone. ECONOMIC EVENTS: In the U.S., the Chicago Fed's National Activity index jumped to 0.39 in July from an upwardly revised 0.21 in June. Markit's preliminary August services PMI came in at 58.5, which was down from a prior reading of 60.8 but above the 58.0 consensus projection. New home sales dropped 2.4% to a 412K rate in July, missing expectations for them to have risen to a 430K annualized rate. COMPANY NEWS: Shares of InterMune (ITMN) surged 35.5% to trade just below $73 per share near noon after the company agreed to be acquired by Roche (RHHBY) for $74.00 per share in an all-cash transaction. The deal announcement comes less than two weeks after Bloomberg reported that Roche, along with big pharmaceutical peers Sanofi (SNY) and GlaxoSmithKline (GSK), had made takeover bids for the smaller drugmaker. A number of other biotech companies gained following the deal announcement, including Gilead (GILD), which rose about 3%, and Celgene (CELG), which advanced 2%... Burger King (BKW) shares rose 19% after the company confirmed it is in talks regarding a potential strategic transaction with Canadian donut chain Tim Hortons (THI). The new publicly-listed company, which would be headquartered in Canada, would be the world's third-largest quick service restaurant company with about $22B in system sales and over 18,000 restaurants. Shares of Tim Horton's trading in New York also gained 20% following the confirmation of news reported by The Wall Street Journal over the weekend. MAJOR MOVERS: Among the notable gainers was Life Time Fitness (LTM), which rose 10% after confirming the company has initiated a process to explore a potential conversion of its real estate assets into a Real Estate Investment Trust, or REIT. Also higher was Ann Inc. (ANN), which gained 4.5% after Engine Capital and Red Alder, who collectively own over 1% of the company's outstanding shares, urged the company to explore value creating opportunities, including a potential sale. Among the noteworthy losers was Regado Biosciences (RGDO), which plunged 60% and was downgraded at Deutsche Bank and Jefferies after the company announced the permanent termination of enrollment in its REGULATE-PCI phase 3 trial for its lead program. Also lower after its earnings report was Chinese Internet services provider Qihoo 360 (QIHU), which dropped 8%. INDEXES: Near midday, the Dow was up 96.27, or 0.57%, to 17,097.49, the Nasdaq was up 21.29, or 0.47%, to 4,559.85, and the S&P 500 was up 11.14, or 0.56%, to 1,999.54.
News For BKW;THI;ITMN;RHHBY;RGDO;SNY;GSK;LTM;ANN;QIHU;GILD;CELG From The Last 14 Days
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January 26, 2015
11:00 EDTGILDMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
09:49 EDTGILDActive equity options trading
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09:19 EDTGSKGlaxoSmithKline announces availability of two new products for asthma
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05:15 EDTRHHBYRoche receives FDA clearance for next generation cobas MRSA/SA test
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05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
05:11 EDTGILDGilead expands hepatitis C generic licensing agreements
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January 23, 2015
09:35 EDTGILDGilead mentioned cautiously at Cleveland Research
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08:52 EDTGSKArray BioPharma to hold a conference call
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08:17 EDTRHHBYRoche management to meet with JPMorgan
Meeting to be held in New York on January 29 hosted by JPMorgan.
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.
07:21 EDTCELGCelgene receives positive CHMP opinion for ABRAXANE
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06:39 EDTGSKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
12:30 EDTGSKGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:16 EDTSNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
09:02 EDTRHHBYRoche's Ventana seeks FDA premarket approval for ALK IHC lung cancer assay
Roche Group member Ventana Medical Systems announced its FDA submission for premarket approval of the Ventana ALK CDx Assay. The companion diagnostic immunohistochemistry test is designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene. This submission was the fourth and final module and application required by the FDA's PMA process.
08:36 EDTCELGCelgene price target raised to $139 from $115 at RW Baird
Baird raised its price target on Celgene to $139 from $115 following last week's guidance from the company. Baird reiterated its Outperform rating on Celgene shares.
January 20, 2015
16:00 EDTGILDOptions Update; January 20, 2015
iPath S&P 500 VIX Short-Term Futures down 36c to 35.12 Option volume leaders: AAPL TSLA TWTR GILD NFLX MGM ABX AMAT JNJ C according to Track Data.
09:38 EDTGILDActive equity options trading
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