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News Breaks
August 25, 2014
12:19 EDTBKW, GILD, QIHU, ANN, LTM, GSK, SNY, RGDO, RHHBY, ITMN, THI, CELGOn 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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October 21, 2014
09:37 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL PBR AMZN C TWTR CVX VZ MCD GILD TXN
09:23 EDTCELGCelgene GED-0301 said to have 67% 12-week remission at high dose in trial
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08:45 EDTGILDGilead Hep C drug barely used in California prisons due to cost, SFGate reports
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07:15 EDTRHHBYFDA to hold workshop on breast cancer drug development
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07:06 EDTGSK, SNYFierce Biotech to hold a breakfast meeting
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06:44 EDTSNYActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
13:40 EDTBKWOptions with increasing implied volatility
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13:26 EDTCELGCelgene I&I franchise boosted by Crohn’s trial data, says William Blair
William Blair said it views the preliminary Phase II efficacy and safety data from mongersen in Crohn’s disease reported by Celgene as encouraging. The firm noted that the 10 mg arm did not achieve significance, but the three data points collectively formed a robust dose-response that William Blair said lends support for the drug's proposed mechanism of action. William Blair believes mongersen complements Celgene’s Inflammation & Immunology portfolio and the firm maintains its Outperform rating on the stock, which is up 4% to $91.65 in afternoon trading.
13:21 EDTCELGCelgene reports Phase II data in Crohn’s Disease to be presented at UEG
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12:37 EDTRHHBYOn The Fly: Midday Wrap
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10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the product’s U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
09:36 EDTGILDActive equity options trading on open
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09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
08:06 EDTSNYMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:19 EDTRHHBY, GSK, SNYIBC Life Sciences to hold a conference
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07:11 EDTRHHBYAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTRHHBY, SNYAmerican Society of Human Genetics to hold annual meeting
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07:06 EDTRHHBYNewLink announces worldwide license agreement for NLG919 development
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07:04 EDTRHHBYRoche approval would be positive for TESARO, says Jefferies
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07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
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