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News Breaks
June 16, 2014
07:33 EDTABBV, BIIBBiogen, AbbVie announce results from Phase 3 DECIDE clinical trial
Biogen (BIIB) and AbbVie (ABBV) announced positive top-line results from the Phase 3 DECIDE clinical trial, designed to evaluate the superiority of once-monthly, subcutaneous daclizumab high-yield process when compared to intramuscular interferon beta-1a as a potential treatment for relapsing-remitting multiple sclerosis. Results showed that DAC HYP was superior on the study’s primary endpoint, demonstrating a statistically significant 45% reduction in annualized relapse rate compared to IFN beta-1a. AbbVie Chief Scientific Officer Michael Severino said, "The positive results in the DECIDE study represent achievement of an important milestone in the development of DAC HYP as a potential new treatment option for MS patients. Together, the companies are committed to working with regulatory agencies on filing plans for DAC HYP.” Biogen Idec and AbbVie plan to work with regulatory agencies to determine appropriate timelines for filing.
News For BIIB;ABBV From The Last 14 Days
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March 20, 2015
16:22 EDTBIIBOn The Fly: Closing Wrap
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12:41 EDTBIIBOn The Fly: Midday Wrap
Stocks began the day sharply higher and have continued to tack on gains throughout the morning. The market’s move put the Nasdaq back above 5,000 and the S&P above 2,100. The market is undergoing quadruple witching, which occurs 4 times per year and typically is accompanied by high volume and volatility. ECONOMIC EVENTS: In the U.S., the economic calendar was quiet. The Baker Hughes U.S. rig count, which has been closely watched in recent months amid the protracted slide in oil prices, is expected at 1:00 pm EDT. The count of U.S. rigs stood at 1125 at the end of last week. In Europe, reports indicate German Chancellor Angela Merkel said Greece has agreed to send a list of overhauled reforms to European officials within days. COMPANY NEWS: Shares of Nike (NKE) advanced 4% following its Q3 earnings beat. Credit Suisse raised Nike's price target to $106 following the report, saying Nike's underlying futures growth remains in double-digits and preliminary FY16 guidance suggests management has been effective in managing currency headwinds... The shares of Biogen (BIIB) rallied 8% after the company reported results for an early stage study of its Alzheimer's drug, BIIB-037. The company announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. MAJOR MOVERS: Among the notable gainers was Prothena (PRTA), which surged 30% after announcing results from a Phase 1 single ascending dose study of its potential treatment of Parkinson's disease. Also higher was Darden Restaurants (DRI), which gained 4% after the owner of the Olive Garden and Long Horn restaurant chains reported earnings that beat expectations. Among the noteworthy losers was China's Youku Tudou (YOKU), which dropped 9% and was downgraded to Sell at Deutsche Bank after the company reported mixed Q4 results. Also lower was Theravance (THRX), which fell 7% after the company and partner GlaxoSmithKline (GSK) announced that an FDA advisory committee voted that the efficacy data for their Breo Ellipta inhaler provides substantial evidence of a clinically meaningful benefit in adults, however it voted against approval for the proposed indication in 12-17 year olds. INDEXES: Near midday, the Dow was up 189.04, or 1.05%, to 18,148.07, the Nasdaq was up 40.24, or 0.81%, to 5,032.62, and the S&P 500 was up 19.54, or 0.94%, to 2,108.81.
11:33 EDTBIIBFly Review: Analysts correctly predict jump in Biogen shares
The shares of Biogen (BIIB) are rallying after the company reported results for a Phase 1b study of its Alzheimer's drug, BIIB-037. On March 18, as reported on that day by The Fly, RBC Capital predicted that the stock would rise after the results were published. A number of other firms were also upbeat on the stock ahead of the data release. WHAT'S NEW: Earlier this morning Biogen announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. Beta amyloid is a protein that produces plaque in the brain. Scientists suspect that plaques in the brain are a cause of Alzheimer's. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. PRE-EVENT CALLS: RBC Capital analyst Michael Yee predicted earlier this week in a note to investors that Biogen would report strong data for BIIB-037 and the stock should "work higher" after the data is unveiled. Alzheimer's patients taking the high dose of Biogen's BIIB-037 drug should exhibit a stabilization of cognition levels, Yee stated. Conversely, the cognition levels of patients taking the placebo should drop slightly, the analyst predicted. On March 13, in a note summarized by The Fly on that day, JPMorgan recommended buying Biogen shares ahead of the data release. Investors still incorporated a low probability of success for the drug, and the stock could rise further, the firm wrote. On March 19, in a note also published by The Fly, Credit Suisse wrote that Biogen's multiple could rise if the data on BIIB-037 was positive. It raised its price target on the name to $500 from $400. ANALYST REACTION: This morning, Barclays raised Biogen's price target to $500 from $435 following the company's report of "impressive" full results from the Alzheimer's study. Piper Jaffray analyst Joshua Schimmer also raised his price target for Biogen shares to $500 this morning, calling today’s BIIB-037 results "robust and impressive." Schimmer believes the trial showed a "consistent and dramatic" dose effect on both radiographic and clinical disease features and thinks the side effects "pale in comparison" to the drug’s efficacy. OTHERS TO WATCH: Eli Lilly (LLY) and Roche (RHHBY) are also currently developing similar Alzheimer's treatments. PRICE ACTION: In late morning trading, Biogen rose 7% to $464. The stock is up about 9% since Wednesday. Eli Lilly shares are up 1.6% to $75.40 this morning, while Roche rose 2.2% to $35. Reference Link
10:51 EDTBIIBBiogen hits fresh 52-week high, retraces, levels to watch
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09:24 EDTBIIBOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Ctrip.com (CTRP), up 20.1%... Rally Software (RALY), up 17.3%... Nike (NKE), up 5.2%... Darden Restaurants (DRI), up 4.3%... Cheetah Mobile (CMCM), up 3.6%. ALSO HIGHER: Prothena (PRTA), up 40.2% after reporting positive results from Phase 1 study of PRX002... Viggle (VGGL), up 26.9% after confirming receipt of offer from chairman and CEO Robert Sillerman... Intercept Pharmaceuticals (ICPT), up 8.5% after announcing new data analyses from FLINT trial... Biogen Idec (BIIB), up 9.7% after presenting positive interim results from study of aducanumab... Pier 1 Imports (PIR), up 5.2% after being upgraded to Outperform from Perform at Oppenheimer... JinkoSolar (JKS), up 2.8% after announcing that it will supply 75 MWdc of its PV solar modules to Red Horse 2 project and following a strategic collaboration agreement with DuPont (DD). DuPont is up just under 1%. DOWN AFTER EARNINGS: AK Steel (AKS), down 6.8%... Youku Tudou (YOKU), down 4.9%... Tiffany (TIF), down 3.3%. ALSO LOWER: Macerich (MAC), down 7.7% after Simon makes $95.50 per share "best and final" offer.
09:01 EDTBIIBEli Lilly up 2% to $75.75 in pre-market trading
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08:42 EDTBIIBBiogen price target raised to $500 from $421 at Piper Jaffray
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07:45 EDTBIIBBiogen price target raised to $500 from $435 at Barclays
Barclays raised Biogen's price target to $500 following impressive full results from the Phase 1b study of BIIB037 in Alzheimer's disease. The data provided evidence of statistically significant benefits and justify the decision to advance into pivotal studies. Shares are Overweight rated.
07:41 EDTABBVAmerican Academy of Dermatology to hold annual meeting
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06:06 EDTBIIBStocks with implied volatility above IV index mean; CTRP BIIB
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05:37 EDTBIIBBiogen presents positive interim results from study of aducanumab
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March 19, 2015
13:07 EDTBIIBBiogen volatility elevated into Alzheimer's data
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08:47 EDTABBVAbbVie and C2N sign worlwide license agreement for Alzheimer's Disease therapy
AbbVie has entered into an exclusive worldwide license agreement with C2N Diagnostics, a privately held protein diagnostic and therapeutic discovery company, to develop and commercialize a portfolio of anti-tau antibodies for the treatment of Alzheimer's Disease and other neurological disorders. Financial terms of the collaboration were not disclosed.
07:56 EDTABBVAbbVie plans $30M expansion at plant in Puerto Rico, AP reports
AbbVie is planning to expand one of its facilities in Barceloneta, Puerto Rico, The Associated Press reports. The $30M expansion is slated for a plant that manufactures products related to immunology, virology and metabolic disorders. Reference Link
07:12 EDTBIIBBiogen price target raised to $500 from $400 at Credit Suisse
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March 18, 2015
12:48 EDTBIIBFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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07:34 EDTBIIBBiogen should report strong Alzheimer's data, says RBC Capital
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March 17, 2015
08:03 EDTABBVAbbVie to present data from 22 HUMIRA abstracts at AAD
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06:31 EDTABBVStudies find Gilead's hepatitis C drugs cost effective, Reuters says
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March 16, 2015
15:04 EDTABBVPharmacyclics says committee recommends unblinding after primary endpoint met
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