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News Breaks
June 12, 2014
09:25 EDTACOR, ACOR, GENZ, GENZ, NVS, NVS, BIIB, BIIBPiper Jaffray biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses the current and developing treatment landscape for Multiple Sclerosis including Biogen Idec's Tecfidera, Genzyme's Aubagio, Novartis' Gilenya, Acorda's Ampyra on an Analyst/Industry conference call to be held on June 13 at 9:45 am.
News For ACOR;GENZ;NVS;BIIB From The Last 14 Days
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March 20, 2015
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
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 EDTNVSAmerican 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
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
13:07 EDTBIIBBiogen volatility elevated into Alzheimer's data
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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
12:51 EDTNVSNovartis hit with $100M gender discrimination lawsuit, Reuters reports
A proposed class action lawsuit against Novartis claims the drug maker routinely denied female employees equal pay and promotional opportunities, reports Reuters. The $110M lawsuit filed on Tuesday says Novartis' Alcon Laboratories maintains a "boy's club atmosphere" that is hostile to women and bars them from leadership positions. Reference Link
05:32 EDTNVSIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.
March 16, 2015
09:01 EDTACORFlex Pharma names Thomas Wessel as Chief Medical Officer
Flex Pharma (FLKS) announced the appointment of Thomas Wessel, M.D., Ph.D., as its Chief Medical Officer, reporting to Christoph Westphal M.D., Ph.D., Flex Pharma’s President, CEO and Chair. Flex Pharma also announced that Elizabeth Woo, M.B.A., has been promoted to Senior VP, Investor Relations and Corporate Communications. Previously, Dr. Wessel has been the Chief Medical Officer of Acorda Therapeutics (ACOR).
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