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Stock Market & Financial Investment News

News For VVUS;JNJ;AZN;PFE From The Last 14 Days
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October 22, 2014
07:35 EDTAZNCardiometabolic Health Congress to hold annual meeting
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05:31 EDTJNJJohnson & Johnson announces commitment to speed Ebola vaccine development
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October 21, 2014
07:15 EDTPFE, AZNFDA to hold workshop on breast cancer drug development
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07:06 EDTPFEFierce Biotech to hold a breakfast meeting
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06:10 EDTAZNInovio, MedImmune, UPENN awarded $12.2M collaborative study by DARPA
Inovio Pharmaceuticals (INO) announced the Defense Advanced Research Projects Agency, or DARPA, has awarded $12.2M for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The group will develop DNA-based monoclonal antibodies, or mAbs, for infectious disease treatment. DARPA is an agency of the US Department of Defense that creates and supports novel technologies important for national security. Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas – influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.
October 20, 2014
12:36 EDTJNJOptions with decreasing implied volatility
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08:14 EDTJNJPharmacyclics files supplmeental NDA for Imbruvica for macroglobulinemia
Pharmacyclics (PCYC) announced that it has submitted a supplemental New Drug Application to the FDA based on data from a Phase 2 study evaluating the use of IMBRUVICA in patients with Waldenstrom's macroglobulinemia. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
07:47 EDTAZN, PFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:19 EDTAZNIBC Life Sciences to hold a conference
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:14 EDTAZNEuropean College of Neuropsychopharmacology to hold a conference
27th ECNP Congress is being held in Berlin, Germany on October 18-21.
07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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October 17, 2014
16:55 EDTJNJStocks end volatile week lower amid oil price plunge
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16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
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08:57 EDTJNJPharmacyclics price target raised to $188 from $185 at Roth Capital
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08:51 EDTJNJPharmacyclics announces European approval for Imbruvica
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08:02 EDTJNJCovidien granted preliminary injunction against Ethicon's Harmonic ACE+7
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October 16, 2014
14:47 EDTJNJRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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October 15, 2014
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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10:48 EDTAZNShire tanks with AbbVie calling board meeting over merger
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09:57 EDTJNJLeerink biotech analysts hold an analyst/industry conference call
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09:38 EDTJNJActive equity options trading on open
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09:15 EDTJNJJ&J comments positive for Anika Therapeutics, says Summer Street
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07:37 EDTJNJJohnson & Johnson pullback a buying opportunity, says Leerink
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07:34 EDTJNJJohnson & Johnson reported strong Q3 results, says Argus
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07:14 EDTJNJJohnson & Johnson price target lowered to $110-$111 from $119-$120 at Wells Fargo
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October 14, 2014
16:22 EDTJNJOn The Fly: Closing Wrap
The Wall Street averages were mixed after three of the U.S.'s largest banks reported on their quarterly results and Germany slashed its economic forecasts for this year and next. Following the mostly solid earnings reports from the banks and Dow member Johnson & Johnson (JNJ) investors appeared to breathe a sigh of relief and sent the averages higher in early trading. With oil prices falling almost 5% and settling at a recent low, the averages pared their gains and struggled in positive ground. Another late day slide ended with the averages mixed, as the Nasdaq led and the Dow lagged. ECONOMIC EVENTS: In the U.S., the International Energy Agency said in its monthly oil market report that world oil demand growth would be weaker than previously expected. Afterward, WTI crude oil futures fell 4.6% at $81.84, marking their biggest percentage drop since late 2012 and the lowest settlement for the benchmark in over two years. The National Federation of Independent Business' small business optimism index came in at 95.3, versus the consensus expectation for a 95.8 reading. In Europe, Germany's government cut its forecasts for gross domestic product growth to 1.2% in 2014 and 1.3% next year from its prior view of 1.8% growth this year and 2% in 2015. COMPANY NEWS: The first of America's big banks issued their quarterly reports, with JPMorgan's (JPM) headline earnings per share coming in below analysts’ consensus estimate, Wells Fargo (WFC) reporting in-line earnings and improved credit quality and Citigroup (C) posting better than expected adjusted third quarter profit. Citi, which also announced plans to pull back from retail banking in eleven countries and said it will disband a legacy Banamex unit after an investigation uncovered illegal conduct, saw its stock fare the best among the three, rising $1.57, or 3.15%, to $51.47... Another Dow member, Johnson & Johnson, reported better than expected profits and revenues and raised its FY14 EPS outlook, but its stock slid $2.11, or 2.13%, to $97.01. MAJOR MOVERS: Among the notable gainers was Domino's Pizza (DPZ), which rose $8.58, or 11.33%, to $84.30 after the pizza chain owner and franchisor reported better than expected third quarter earnings per share and revenue. Also higher was Skyworks (SWKS), which advanced $3.59, or 7.92%, to $48.91 after the supplier of chips to Apple (AAPL) raised its fourth quarter earnings per share outlook and revenue guidance. Among the noteworthy losers was Exactech (EXAC), which dropped $4.09, or 16.63%, to $20.50 after the company warned its Q3 income and revenue will likely miss its prior guidance. Also lower were shares of Gilead (GILD), which fell $4.26, or 4.2%, to $97.18 amid a number of developments. Competitor Johnson & Johnson said it would seek to make its own hepatitis C treatment accessible and "competitive," which some may have read as an indication of a potential price cut, and Ireland said it plans to close its "Irish Double" tax loophole, which currently benefits Gilead. INDEXES: The Dow slipped 5.88, or 0.04%, to 16,315.19, the Nasdaq rose 13.52, or 0.32%, to 4,227.17, and the S&P 500 added 2.96, or 0.16%, to 1,877.70.
12:41 EDTJNJGilead retreats following Johnson & Johnson comments on HCV drug
Shares of Gilead (GILD), which has developed a hepatitis C treatment, are retreating after Johnson & Johnson (JNJ) said it would seek to make its own hepatitis C treatment accessible and competitive. Some investors believe that Johnson & Johnson's comments suggest that it will cut the price of its hepatitis C drug. WHAT'S NEW: Johnson & Johnson said on its earnings conference call today that it was "committed" to its treatment for hepatitis C virus, or HCV. The company added that it intends to remain competitive in the space and would look to make its HCV treatment, Olysio, accessible. In a separate development today, The Wall Street Journal reported that Abbvie (ABBV), which also has an HCV treatment, may have to consider pricing its HCV drug more aggressively after Gilead received FDA approval for Harvoni, the first combination pill approved to treat chronic HCV genotype 1 infection. One analyst quoted by The Journal, Roger Longman, said that AbbVie should consider pricing its drug at $76,000 for a 12 week regimen, representing a 20% discount to Harvoni, which will be priced at $94,500 for a full 12 week regimen. ANALYST REACTION: In a note to investors earlier today, RBC Capital analyst Michael Yee wrote that the weakness in Gilead's stock today has created a buying opportunity. Johnson & Johnson probably can't reduce the price of its Olysio drug much, since it is often used in combination with Gilead's Sovaldi, which costs $84,000 for 12 weeks, RBC Capital analyst Michael Yee wrote in a note to investors today. The price of AbbVie's treatment is unlikely to be much below Sovaldi's price, the analyst stated. WHAT'S NOTABLE: Gilead, along with a number of other drug companies, may also be under pressure because Ireland is reportedly closing its "Irish Double" tax loophole. Gilead is one of the companies that currently benefits from the "Irish Double," but Yee says that closing the loophole should only have a "minimal" impact on Gilead. PRICE ACTION: In early afternoon trading, Gilead fell 3.3% to $98.10, AbbVie gained 1.7% to $54.53 and Johnson & Johnson lost 0.6% to $98.52.
12:33 EDTJNJZimmer, Stryker have postive read-through from J&J, says Wells Fargo
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12:20 EDTJNJOn The Fly: Midday Wrap
Stocks on Wall Street were higher at midday after three of the nation's largest banks reported on their results in the most recent quarter of the year. The market began the session in positive territory but the move seemed tenuous and the averages were almost back in negative ground within a half hour of the opening bell. As the morning progressed and the bears were unable to gain control, the buyers emerged and pushed the Dow to a triple digit gain and the Nasdaq to an increase of nearly 1.5%. ECONOMIC EVENTS: In the U.S., the National Federation of Independent Business' small business optimism index came in at 95.3, versus the consensus expectation for a 95.8 reading. COMPANY NEWS: JPMorgan (JPM) swung to a third quarter profit, but its headline earnings per share fell below analysts’ consensus estimate. Of note, the company's press release on its results came out earlier than planned on Nasdaq's (NDAQ) Shareholder.com website, which the exchange operator attributed to an internal "human error." Wells Fargo (WFC) reported in-line earnings and stronger credit quality, but its stock slid 1.4% following the report. Citigroup (C) generated the most headlines, however, as it reported better than expected adjusted third quarter profit, announced plans to pull back from retail banking in eleven countries and said it will disband a legacy Banamex unit that provided personal security services after an investigation uncovered illegal conduct. Shares of Citi bucked the trend set by its two peers, rising 3% near noon... In addition to JPMorgan, Dow member Johnson & Johnson (JNJ) reported on its third quarter earnings. The drug and medical device giant reported better than expected profits and revenues and raised its FY14 EPS outlook, but the stock was fractionally lower near midday. MAJOR MOVERS: Among the notable gainers was Energy Transfer Equity (ETE), which gained 8.5% after the stock was among the energy industry names upgraded this morning at RW Baird. Also higher was Skyworks (SWKS), which rose 11% after the company preannounced stronger than expected results that its CEO attributed to the "broad-based strength" of its business. Among the noteworthy losers was EnerNOC (ENOC), which dropped 11% after JPMorgan downgraded the stock to Neutral citing risk to the company's Demand Response revenue at PJM given the challenge to FERC Rule 745. Also lower was Tyco (TYC), which fell nearly 4% after Barclays downgraded the stock citing valuation and coupled the ratings change with an upgrade of Eaton (ETN). INDEXES: Near midday, the Dow was up 133.38, or 0.82%, to 16,454.45, the Nasdaq was up 60.63, or 1.44%, to 4,274.29, and the S&P 500 was up 21.51, or 1.15%, to 1,896.25.
11:23 EDTPFE, JNJ, AZNBIND Therapeutics and The Conference Forum hold a conference
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11:11 EDTJNJJohnson & Johnson Ortho strength positive for Zimmer, says Piper Jaffray
Piper Jaffray said Johnson & Johnson's (JNJ) sequential Q3 strength in orthopedics, which included acceleration in both hips and knees, was surprising and a positive for Zimmer (ZMH). However, Piper expect sentiments on ortho names to remain muted until further into reporting season, noting that Stryker (SYK) is scheduled to report Thursday after the close. The firm has Neutral rating on Johnson & Johnson and Stryker and an Overweight rating on Zimmer.
10:51 EDTJNJGilead weakness a buying opportunity, says RBC Capital
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10:41 EDTJNJGilead weakness a buying opportunity, says RBC Capital
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10:05 EDTJNJAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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09:14 EDTJNJJ&J sees FY14 pre-tax operating margin significantly improved vs. FY13
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09:13 EDTJNJOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Johnson & Johnson (JNJ), up 1%... Dominos Pizza (DPZ), up 2.7%. ALSO HIGHER: Citigroup (C), up 2.5% following earnings report, announcement of plans to exit consumer businesses in 11 markets... MagneGas (MNGA), up 14% after signing Letter of Intent with Pioneer Recycling... Skyworks (SWKS), up 6% after raising its outlook for Q4. Shares of peers Avago (AVGO), NXP Semiconductors (NXPI) and RF Micro Devices (RFMD) are also moving higher in pre-market trading after Skyworks pointed to "broad-based strength" of its business in raising its outlook... Halcon Resources (HK), up 6% after upgraded at KLR Group... Quantum (QTM), up 8.8% after issuing Q2 earnings guidance. LOWER: Wells Fargo (WFC), down 1.4% after reporting in-line Q3 earnings... JPMorgan (JPM), down 1.8% after Q3 headline earnings miss... Las Vegas Sands (LVS), down 1% following downgrade at BofA Merrill Lynch.
08:58 EDTJNJJ&J sees FY14 operating sales on constant currency basis up 5.5%-6.5%
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07:50 EDTJNJJohnson & Johnson: Alios BioPharma transaction expected to close in Q4 of 2014
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07:50 EDTJNJJohnson & Johnson reports Q3 Worldwide Consumer sales down 0.6% to $3.6B
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07:49 EDTJNJJohnson & Johnson raises FY14 EPS to $5.92-$5.97 from $5.85-$5.92
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07:48 EDTJNJJohnson & Johnson reports Q3 domestic sales up 11.6% to $8.84B
Reports Q3 international sales down 0.3% to $9.63B. Worldwide, domestic and international operational sales growth, excluding the impact of this divestiture, was 8.4%; 14.8% and 3.1% respectively.
07:46 EDTJNJJohnson & Johnson reports Q3 adjusted EPS $1.50, consensus $1.44
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October 13, 2014
15:24 EDTJNJNotable companies reporting before tomorrow's open
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14:24 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
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14:15 EDTJNJEarnings Preview: Johnson & Johnson looks to new drugs to boost Q3 sales
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14:08 EDTJNJJohnson & Johnson technical notes before earnings
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10:08 EDTAZNOn The Fly: Analyst Upgrade Summary
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09:21 EDTAZNOn The Fly: Pre-market Movers
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08:40 EDTJNJAlios BioPharma reports positive results for AL-8176 in Phase 2 study
Alios BioPharma presented results from a randomized, double-blind, placebo-controlled Phase 2 challenge study of its oral anti-RSV nucleoside analog AL-8176 this past weekend at the IDWeek 2014 Conference in Philadelphia, PA. The study was conducted in healthy adult volunteers who were infected intranasally with respiratory syncytial virus, or RSV. AL-8176 achieved its primary and secondary endpoints of reduction in viral load and improvement in symptom scores as compared to placebo. AL-8176 was well tolerated with no discontinuations of study drug and no clinically significant laboratory abnormalities. In successfully infected subjects, a rapid and marked reduction in RSV viral load was observed following treatment in all three AL-8176 treated dose groups as compared to placebo. In contrast, successfully infected placebo subjects exhibited a logarithmic increase in RSV RNA with a peak viral load at Day 3.5 following start of dosing with placebo. The mean time to non-detectability of RSV RNA was 1.3-2.3 days for the AL-8176 treatment groups compared to 7.2 days in the placebo group. At discharge, all subjects treated with AL-8176 were RSV RNA undetectable and remained RSV RNA undetectable upon follow-up on Days 16 and 28. The viral load reduction in infected subjects across all AL-8176 dosing regimens was associated with concomitant improvements in RSV symptom scores and reductions in mucus weight. On September 30, Johnson & Johnson announced a definitive agreement to acquire Alios.
08:05 EDTJNJBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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07:53 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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07:25 EDTJNJEuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
07:15 EDTJNJNational Association of Corporate Directors to hold a conference
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07:13 EDTJNJBioFlorida to hold a conference
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05:27 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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October 10, 2014
10:01 EDTJNJOn The Fly: Analyst Upgrade Summary
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08:19 EDTJNJMedivir announces Janssen initiates enrolment in phase II IMPACT study
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08:15 EDTJNJJohnson & Johnson reports additional data from ATTAIN study
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08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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07:07 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
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06:27 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
October 9, 2014
08:10 EDTAZNAstraZeneca reports Phase IIb study of benralizumab met primary endpoint
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October 8, 2014
10:55 EDTPFELeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
08:09 EDTPFEPfizer presents LP2086 Phase 2 study data
Pfizer announced it will present the results of a Phase 2, randomized study to evaluate co-administration of the company’s investigational meningococcal group B vaccine, bivalent recombinant LP2086, or rLP2086, with a licensed quadrivalent human papillomavirus vaccine at IDWeek 2014. Data demonstrated immune responses to both vaccines were generated after concomitant administration of bivalent rLP2086 and HPV4. Prespecified noninferiority criteria were met for the bivalent rLP2086 antigens studied and three of the four antigens for HPV4. Primary immunogenicity endpoints, measured after the third dose, included geometric mean titers against HPV antigens in Groups 1 and 3 and human complement serum bactericidal assay GMTs against meningococcal group B disease test strains in Groups 1 and 2. Secondary immunogenicity endpoints included the rate of seroconversion to HPV antigens. Safety of bivalent rLP2086 was assessed after concomitant administration with HPV4 or saline. The prespecified noninferiority criteria were met for three of four HPV antigens and both meningococcal group B disease test strains. Seroconversion for all four HPV antigens was achieved by 99% or more of the subjects for the groups that received HPV4 concomitantly with bivalent rLP2086 or with saline. More local reactions occurred following administration of bivalent rLP2086 compared with saline but the incidence of these reactions did not increase with subsequent vaccine administration. The rates of local and systemic reactions were comparable when bivalent rLP2086 was given with HPV4 to bivalent rLP2086 given alone.
07:19 EDTPFECBI to hold a conference
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07:18 EDTPFEInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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