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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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March 23, 2015
09:37 EDTSHPG, PFE, CELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AUY SLB PFE MCP CELG VRTX SHPG GILD LOGI TSLA TASR NFLX SCTY WFM
09:03 EDTNVS, JNJLeerink analysts hold a meeting with a conference call hookup
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09:03 EDTABTFiserv says Abbott employee credit union expands partnership
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08:06 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
Pfizer (PFE) and Eli Lilly and Company (LLY) announced that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200M upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. FDA to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February. In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
08:05 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
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07:36 EDTPFE, GSK, SHPGPfizer 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.
07:17 EDTMRKAmerican Academy of Dermatology to hold annual meeting
73rd Annual Meeting of AAD is being held in San Francisco on March 20-24.
05:55 EDTCELGStocks with implied volatility movement; AMZN CELG
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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
13:04 EDTCELGCelgene reports results from long-term efficacy,safety analyses of Otezla trials
Celgene announced that results from long-term efficacy and safety analyses of the ESTEEM phase III clinical trial program of Otezla were presented at the 73rd Annual Meeting of the American Academy of Dermatology. OTEZLA is the companyís oral, selective inhibitor of phosphodiesterase 4 approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis. In ESTEEM 1 and 2, patients were randomized to treatment with OTEZLA 30 mg twice daily or placebo for the first 16 weeks. At week 16, patients either continued on OTEZLA or were switched from placebo to OTEZLA 30 mg twice daily through week 32. Patients initially randomized to OTEZLA who achieved a Psoriasis Area and Severity Index-75 response or PASI-50 response at week 32 were then re-randomized to either OTEZLA 30 mg twice daily or placebo. Celgene said improvements in the severity of preexisting nail, scalp and palmoplantar psoriasis achieved at week 16 were maintained in OTEZLA responders through week 52 in ESTEEM 2; OTEZLA improved the severity of palmoplantar psoriasis at week 16 in a subset of patients across three trials; Long-term safety profile for up to 104 weeks in ESTEEM 1 was consistent with previously reported data from OTEZLA clinical trial programs, with no new safety signals and no clinically meaningful changes in laboratory values.
13:03 EDTPFEPfizer says oral tofacitinib meets primary endpoint in Phase 3 trials
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13:01 EDTCELGCelgene announces positive Phase III study results evaluating Otezla
Celgene announced that results from its ongoing phase III LIBERATE trial evaluating Otezla, the companyís oral, selective inhibitor of phosphodiesterase 4, in patients with moderate to severe plaque psoriasis. The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16. At week 16, patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index-75 response. At week 16, statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg when compared with placebo. A post-hoc analysis revealed no significant difference between OTEZLA and etanercept in PASI-75 at week 16. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
12:41 EDTGSKOn The Fly: Midday Wrap
Stocks began the day sharply higher and have continued to tack on gains throughout the morning. The marketís 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.
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.
10:51 EDTCELGStocks with call strike movement; DAL CELG
Delta Air Lines (DAL) September 57.5 call option implied volatility decreased 1% to 34, Celgene (CELG) July 145 call option implied volatility increased 3% to 28 according to IVolatility.
10:00 EDTSHPGOn The Fly: Analyst Upgrade Summary
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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.
09:45 EDTCELGActive equity options trading on open
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09:41 EDTSHPGBernstein global specialty pharma analyst holds analyst/industry conference call
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08:12 EDTSHPGShire upgraded to Outperform from Market Perform at Bernstein
Bernstein upgraded Shire as the firm thinks that the stock's risk/reward ratio is positive following several new developments. Among these developments are the firm's belief that the company's orphan drug strategy looks increasingly strong, while the risks to the company's Vyvanse and mesalamines drugs look to have moderated and the company has several near-term, 2015 catalysts. Target $295.
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