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Stock Market & Financial Investment News

News For BIIB;RHHBY;GSK From The Last 14 Days
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March 30, 2015
07:48 EDTRHHBYAcquisition of BioMarin would make sense for several companies, says SunTrust
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07:24 EDTRHHBYStifel to hold a bus tour
BioTrek: 2015 West Coast Healthcare Therapeutics Bus Tour travels throughout San Francisco on March 30-April 1.
05:23 EDTBIIBBiogen announces EMA validation of MAA for SB2
Biogen announced the Marketing Authorization Application, or MAA, for SB2, its biosimilar infliximab candidate using Remicade as the reference product, has been validated for review by the European Medicines Agency, or EMA. The MAA was submitted by the company’s joint venture partner, Samsung Bioepis. This is the second MAA validated for review by the EMA as part of the joint venture. The first, SB4, a biosimilar etanercept candidate referencing Enbrel , was validated for review earlier this year.
March 29, 2015
15:46 EDTGSKGSK reaches agreement with UK on meningitis B vaccine
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March 27, 2015
07:07 EDTBIIBBiogen, AbbVie say EMA validates MAA for Zinbryta for treatment of MS
Biogen (BIIB) and AbbVie (ABBV) announced that the European Medicines Agency has validated the companies’ Marketing Authorisation Application for ZINBRYTA for the treatment of relapsing forms of multiple sclerosis in the European Union. Validation confirms that the submission is complete and signifies the initiation of the review process by the EMA’s Committee for Medicinal Products for Human Use. The MAA included results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg was administered subcutaneously every four weeks in people with relapsing-remitting MS. Biogen and AbbVie are jointly developing ZINBRYTA.
March 26, 2015
11:13 EDTRHHBY, GSKBofA/Merrill European pharma analyst holds an analyst/industry conference call
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06:45 EDTBIIBBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 25, 2015
15:10 EDTRHHBYFoundation Medicine to host special shareholder meeting
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10:35 EDTRHHBYFDA approves expanded indication for Eylea
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07:16 EDTBIIBPiper Jaffray and the Alliance for Regenerative Medicine co-host conference
3rd Annual Regenerative Medicine Investor Day is being held in New York on March 25 with webcasted company presentations to begin at 8 am; not all company presentations may be webcasted. Webcast Link
March 24, 2015
07:45 EDTRHHBY, GSKFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 23, 2015
10:00 EDTBIIBOn The Fly: Analyst Downgrade Summary
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09:45 EDTGSKUBS to hold a field trip
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08:46 EDTRHHBY, BIIBEli Lilly price target raised to $85 from $78 at Cowen
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08:38 EDTBIIBBiogen price target raised to $525 from $418 at Morgan Stanley
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07:36 EDTGSKPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
07:11 EDTBIIBBiogen downgraded at Stifel
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06:34 EDTBIIBBiogen downgraded to Hold from Buy at Stifel
06:32 EDTRHHBYFoundation Medicine announces board changes in connection to Roche transaction
Foundation Medicine (FMI) announced proposed changes to its board in connection with its pending strategic collaboration with Roche (RHHBY). Under the terms of the agreement with Roche, Foundation Medicine’s board will increase to nine directors upon the closing of the transaction, including three board designees selected by Roche. The pending transaction with Roche remains subject to the satisfaction of certain closing conditions, including the successful completion of the tender offer commenced by Roche on February 2, 2015 and the approval of certain matters at the special meeting of Foundation Medicine stockholders to be held on April 2, 2015. The closing is expected to occur in the second quarter of 2015.
06:28 EDTBIIBBiogen price target raised to $512 from $410 at Citigroup
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06:19 EDTBIIBBiogen Idec says becomes Biogen
Effective today, Biogen Idec is known simply as Biogen. The company has introduced a new corporate identity and logo that reflect both its evolution and focus on bringing forth new therapies in areas of high unmet need – while honoring Biogen’s scientific heritage and legacy as a pioneer in the biotechnology industry. Biogen Idec was created in 2003 through the merger of Biogen and IDEC Pharmaceuticals, creating one of the world’s leading research-based life sciences organizations. The company has since focused its research and commercial efforts in three core areas: neurology, immunology and hematology. Biogen’s common stock will continue to trade on the Nasdaq Global Select Market under the symbol “BIIB,” and its CUSIP number will not change.
March 22, 2015
15:17 EDTGSKGSK looks to conclude negotiations with U.K. on vaccine cost, Bloomberg says
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March 20, 2015
17:42 EDTBIIBBiogen has room to run higher, Barron's reports
Biogen’s experimental Alzheimer’s drug BIIB-037 is showing promising trial results and has helped push the stock to all-time highs. Shares could move higher still as the market for an effective Alzheimer’s therapy is worth tens of billions of dollars and Biogen is poised to capitalize on it, Barron's reports. Reference Link
16:33 EDTBIIBStocks end week higher after market reads Fed statement as dovish
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16:22 EDTBIIBOn The Fly: Closing Wrap
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12:41 EDTGSK, BIIBOn 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 EDTRHHBY, BIIBFly 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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09:47 EDTGSKGlaxoSmithKline, Theravance launch Revlar Ellipta in Italy
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Revlar Ellipta in Italy following the recent approval by the Italian regulatory authorities in December 2014. Relvar is a fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. The components will be administered using the Ellipta, a dry powder inhaler. In Italy, the product is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product is appropriate; and for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease with a FEV1<70% predicted normal post-bronchodilator with an exacerbation history despite regular bronchodilator therapy.
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 EDTBIIB, RHHBYEli 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.
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
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
16:14 EDTRHHBYProthena report positive results from Phase 1 study of PRX002
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15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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13:07 EDTBIIBBiogen volatility elevated into Alzheimer's data
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07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREO® ELLIPTA®), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:12 EDTBIIBBiogen price target raised to $500 from $400 at Credit Suisse
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07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
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07:02 EDTRHHBYSigma-Aldrich signs exclusive distribution agreement with Roche
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March 18, 2015
12:48 EDTRHHBY, BIIBFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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07:46 EDTRHHBYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
07:34 EDTBIIBBiogen should report strong Alzheimer's data, says RBC Capital
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March 17, 2015
08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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