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Stock Market & Financial Investment News

News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
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October 24, 2014
13:35 EDTMRKMerck weekly volatility elevated into Q3 and outlook
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11:18 EDTAGNEarnings Preview: Allergan price target raised by Citi ahaead of Q3 results
Allergan (AGN) is estimated to report third quarter earnings before the market open on Monday, October 27. Allergan operates as a multi-specialty healthcare company primarily in the United States, Europe, Latin America, and the Asia Pacific. The company discovers, develops, and commercializes pharmaceutical, biological, medical device, and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatological, breast aesthetics, urological, and other specialty markets. EXPECTATIONS: Analysts are looking for earnings per share of $1.68 on revenue of $1.78B, according to First Call. The consensus range for EPS is $1.45-$1.78 on revenue of $1.69B-$1.85B. LAST QUARTER: Allergan reported second quarter EPS of $1.51 against estimates of $1.44 on revenue of $1.86B against estimates of $1.77B. GUIDANCE: Allergan raised its Q3 EPS view on October 9. The company said it sees a Q3 EPS range of $1.76-$1.78, up from its prior view of $1.44-$1.47. The company also gave full year 2014 EPS guidance of $6.20-$6.25, saying it expected FY14 product net sales to increase 14%-15% compared to product net sales in FY13. Allergan said momentum derived from many sources, including robust growth of worldwide markets in which the company operates, increases in market share in most categories, many regulatory approvals for new products in the U.S. and internationally, and targeted investments to create and grow new products and new categories. The company added that exceptional growth in EPS stems from the acceleration in sales, but also in leveraging of sales and marketing expenditures. The benefits from Allergan’s previously announced restructuring program will be reflected in the company’s actual results beginning in Q4 and continuing through 2015. With the release of the guidance, Allergan CEO David Pyott said, "Today’s announced expectations for the third quarter and updated future outlook further demonstrate that there is a vast value gap between Valeant’s offer and the intrinsic value of Allergan." HOSTILE TAKEOVER: Allergan is in the midst of a hostile takeover attempt at the hands of Valeant (VRX) and Bill Ackman's Pershing Square. On October 20, Valeant said it may raise its bid for Allergan, and will not abandon its pursuit before Allergan's special meeting of shareholders on December 18. At the special meeting, Ackman is looking to replace members of Allergan's board with his own nominees that would be ready to discuss a takeover. STREET RESEARCH: On October 20, Citigroup raised its price target for Allergan (AGN) shares to $210 citing the company's recently increased guidance. Citi believes the three guidance increases this year underscores Allergan's attractiveness as a takeover target. The firm maintained a Buy rating on Allergan shares. PRICE ACTION: Shares of Allergan are up almost 9% since its last earnings report and are higher by 1.6% in Friday's trading ahead of the expected earnings report.
11:00 EDTAMGNAmgen unlikely to split, dealReporter says citing sources
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08:15 EDTJNJJohnson & Johnson management to meet with JPMorgan
Meetings to be held in Chicago/Kansas City on October 29 hosted by JPMorgan.
08:07 EDTAMGNAmgen to hold business review meeting
Business Review Meeting is being held in New York on October 28 at 8 am. Webcast Link
07:51 EDTSHPGShire raises FY14 adjusted EPS growth view to high 30% range
Shire CEO Flemming Ornskov said, "Our early and late stage pipeline continues to be strengthened, both internally, and through business development providing us with new investments in Ophthalmology and Rare Diseases. The FDA accepted with priority review our supplemental new drug application for VYVANSE as a treatment for adults with binge eating disorder and we expect to learn about the potential expanded indication in February 2015. Our strong momentum and performance this quarter is evidence of our ability to deliver growth, efficiency and innovation through our commitment to addressing significant unmet need in Rare Diseases and high-value specialty conditions. As a result, I am pleased to once again increase our guidance for 2014. We now expect to deliver Non GAAP diluted earnings per ADS growth in the high thirty percent range in 2014.”
07:50 EDTSHPGShire repeats commitment to double products sales to $10B by 2020
Shire Chairman Susan Kilsby said: “Shire is well-positioned for future growth as we implement our plan to double product sales to $10B by 2020. I am confident that Shire, as an independent company, will deliver long-term value to our shareholders and improved outcomes for patients. On behalf of the Board of Directors, I would like to thank the Shire management team and employees for the achievement of outstanding financial results during the third quarter.”
07:49 EDTSHPGShire reports Q3 EPS $2.93, consensus $2.48
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06:49 EDTPFEPfizer repurchase could squash AstraZeneca bid goal, Reuters says
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06:32 EDTJNJJohnson & Johnson found 'not liable' in all-metal hip implant suit, WSJ reports
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October 23, 2014
18:52 EDTPFEOn The Fly: After Hours Movers
UP AFTER EARNINGS: Rubicon Project (RUBI), up 19.2%... KLA-Tencor (KLAC), up 15.8%... Gigamon (GIMO), up 13.5%... Maxwell (MXWL), up 11.3%... Qlik Technologies (QLIK), up 9.8%... NetSuite (N), up 5.5%... Microsoft (MSFT), up 3.3%... Juniper Networks (JNPR), reverses in after-hours trading and is up 1.4% after reporting third quarter results and announcing a $1.1B increase to the company's share repurchase authorization. ALSO HIGHER: Vitae Pharmaceuticals (VTAE), up 38.6% following positive top-line results from two Phase 1 clinical trials of BI1181181/VTP-37948... Pfizer (PFE), up 1.8% after announcing a new $11B share repurchase program. DOWN AFTER EARNINGS: Amazon.com (AMZN), down 10.7%... Synaptics(SYNA), down 12.7%... Pandora (P), down 6.8%... Lattice Semiconductor (LSCC), down 5.6%... Maxim Integrated (MXIM), down 5.8%. ALSO LOWER: DryShips (DRYS), down 16.5% after filing an automatic common stock shelf... NPS Pharmaceuticals (NPSP), down 7.9% following PDUFA date for Natpara extended three months to January 24... GoPro (GPRO), down 2.8% after being initiated with an Underperform at Oppenheimer.
18:18 EDTAGN, PFEGlenview Capital acquires stake in Actavis, Bloomberg reports
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16:17 EDTPFEPfizer announces new $11B share repurchase program
The board of directors also authorized a new $11B share repurchase program to be utilized over time. This new program is in addition to the $1.3B of authorization remaining under the company’s current share repurchase program.
10:39 EDTSHPGAbbVie advances after upbeat notes from JPMorgan, Goldman
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08:28 EDTAMGNAmgen may be positioned to split as urged by Loeb, Reuters says
It is not rare for mature pharmaceutical companies to consider, or be called on, to split into "cash" and "growth" companies, but such break-ups rarely happen, according to Reuters' "Breakingviews" columnist Robert Cyran, who contends "Amgen may be the exception" and that activist Dan Loeb "has picked the right target." Reference Link
08:15 EDTPFEPfizer wins SUTENT patent case In Delaware District Court
Pfizer (PFE) announced today that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT capsules. This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021. Pfizer filed suit in June 2010 after Mylan (MYL) applied to the U.S. Food and Drug Administration to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.
05:58 EDTJNJStocks with implied volatility below IV index mean; XLNX JNJ
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October 22, 2014
17:50 EDTJNJBavarian Nordic announces expanded collaboration with Janssen on MVA-BN
Bavarian Nordic A/S announced that it has agreed with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to expand the collaboration announced earlier to include evaluation of Bavarian Nordic's proprietary vaccine platform technology, MVA-BN, for additional undisclosed disease targets. Bavarian Nordic and Janssen will collaborate on the evaluation of MVA-BN for three additional infectious disease targets. Janssen is granted the exclusive option to collaborate on one or more of the targets, following scientific evaluation of MVA-BN-based vaccine candidates, which will be developed by Bavarian Nordic.
09:03 EDTAMGNAmgen treatment of ovarian cancer designated for orphan drug status
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07:35 EDTAMGN, NVO, MRK, SNYCardiometabolic Health Congress to hold annual meeting
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05:58 EDTSHPGStocks with implied volatility movement; MNKD SHPG
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05:31 EDTJNJJohnson & Johnson announces commitment to speed Ebola vaccine development
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October 21, 2014
15:42 EDTAMGNAmgen issues statement regarding Third Point Investment
Amgen issued the following statement with respect to media inquiries concerning Third Point LLC's equity position in Amgen: "Amgen maintains an active, engaged dialogue with all shareholders. Amgen has always appreciated the perspectives of all of its shareholders, including Third Point, and welcomes constructive input toward our common goal of enhancing shareholder value. Amgen's Board of Directors frequently receives input from shareholders, including ideas like those offered by Third Point. The Board and management continually assess Amgen's strategic priorities – and, when appropriate, take action – to set the best path forward to increase shareholder value. Amgen's Board of Directors and management remain focused on addressing significant unmet medical needs for serious illnesses and driving value for all shareholders. We look forward to further updating our shareholders on Amgen's strategic priorities and update on our restructuring plans at our business review on October 28th."
14:25 EDTAMGNAmgen urged by Third Point to split up
In its Q3 investor letter, Dan Loeb's Third Point said it is now one of Amgen's (AMGN) largest shareholders. Amgen's first steps to target its "inflated cost structure" should be applauded, but Third Point believes "much more can and should be done," the firm wrote. Immediate action Amgen can take to create shareholder value include focusing its R&D efforts, providing long-term margin guidance demonstrating a commitment to reducing costs and creating clarity on additional shareholder returns, Third Point also said. Additionally, Third Point said it believes that Amgen could benefit from a separation and should seriously consider breaking up into a "MatureCo" and a "GrowthCo." Shares of Amgen are up 4% to $143.12 in afternoon trading following the circulation of Third Point's Q3 investor letter.
14:09 EDTAMGNThird Point discloses new positions in eBay, Alibaba, exit from Sony
In its Q3 investor letter, Third Point says it established a "significant" position in eBay (EBAY). Dan Loeb's hedge fund also revealed it has established a significant direct investment in Alibaba (BABA) shares now that the company is public. Third Point also said it is now one of Amgen's (AMGN) largest shareholders. During the quarter, Third Point exited its position in Sony (SNE) and reduced or exited other positions, including AIG (AIG), Hertz (HTZ) and Softbank (SFTBF), the firm stated in its letter. PRICE ACTION: Following the disclosures in the Third Point letter, Amgen is up 4%, eBay is up 2.3% and Alibaba is up 3.8%, while Sony shares trading in New York are down nearly 1%.
13:56 EDTAMGNDan Loeb discloses position in Amgen at Robin Hood Conference, CNBC reports
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12:44 EDTAGNMeister says Valeant likely to ultimately raise Allergan bid
Keith Meister of Corvex Management is speaking on CNBC.
12:43 EDTAGNMeister says passive holder of Allergan, aligned with Pershing Square
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09:52 EDTSHPGCovidien rises after Medtronic maintains merger date language
Shares of Covidien (COV) are rising in early trading after Medtronic (MDT), in its latest regulatory filing answering questions for shareholders regarding its proposed takeover of the Irish drugmaker, left its language regarding the expected closing date unchanged. WHAT'S NEW: In its most recent filing, Medtronic again stated, "As of the date of this joint proxy statement/prospectus, the transaction is expected to be completed late in the fourth calendar quarter of 2014 or early 2015. However, no assurance can be provided as to when or if the transaction will be completed. The required vote of Medtronic and Covidien shareholders to adopt the required shareholder proposals at their respective special meetings, as well as the necessary regulatory consents and approvals, must first be obtained and other conditions specified in the conditions appendix must be satisfied or, to the extent applicable, waived." ANALYST REACTION: Research firm BTIG says Medtronic's amended regulatory filing on the Covidien transaction increases the firm's confidence of the deal closing by early 2015. The firm adds it would be "stunned" to see Medtronic walk away from the merger after the company again showed commitment to the acquisition. WHAT'S NOTABLE: AbbVie (ABBV) last night confirmed that the company and Shire (SHPG), another Irish domiciled drugmaker, agreed to terminate their proposed merger. AbbVie said its decision was based upon its assessment of the September 22 notice issued by the U.S. Department of Treasury, which re-interpreted longstanding tax principles in a "uniquely selective manner designed specifically to destroy the financial benefits of these types of transactions." AbbVie continued that the Treasury notice "introduced an unacceptable level of risk and uncertainty given the magnitude of the proposed changes" and the stated intention of the department to continue to revise tax principles to further impact such "tax inversion" transactions. AbbVie noted that it has agreed to pay Shire a break fee of approximately $1.64B due to the deal falling through. PRICE ACTION: In early trading, shares of Covidien trading in New York rose 4% to $88.86, Medtronic advanced 1% to $64.57, Shires gained 0.7% to $185.82 and AbbVie added 1.4% to $55.16.
09:48 EDTSHPGShire could target BioMarin, TheStreet's Feuerstein says
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07:42 EDTAGNValeant Q3 results makes strong case for Allergan purchase, says Susquehanna
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07:15 EDTPFE, AMGNFDA to hold workshop on breast cancer drug development
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07:06 EDTPFE, SNYFierce Biotech to hold a breakfast meeting
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06:44 EDTSNYActavis among bidders for Omega Pharma, Bloomberg reports
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06:33 EDTAGNValeant price target raised to $182 from $167 at Cantor
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October 20, 2014
18:51 EDTSHPGOn The Fly: After Hours Movers
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17:26 EDTSHPGShire down 1% following termination of merger with AbbVie
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17:17 EDTSHPGAbbVie to pay Shire $1.64B break fee
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17:16 EDTSHPGAbbVie, Shire announce termination of proposed merger
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17:14 EDTSHPGAbbVie, Shire announce termination of proposed merger
12:36 EDTJNJOptions with decreasing implied volatility
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12:23 EDTSHPG, AGNAllergan holder Paulson encourages deal with Shire, Reuters says
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12:21 EDTSHPGCooperman says bought Shire as 'small position'
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10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the product’s U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
09:25 EDTAGNValeant says talks to Ackman 'frequently'
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09:22 EDTSHPGOn The Fly: Pre-market Movers
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09:08 EDTAGNValeant says not planning to walk away from Allergan deal before Dec. 18
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08:58 EDTAGNValeant says still willing to improve bid for Allergan
Valeant (VRX) said would raise Allergan (AGN) bid "when time is right." Says hopes Allergan shareholders see that Valeant's operating model does work and will continue to work. Says Valeant (VRX), Allergan have "unique" business overlap. Says company "should" own Allergan. Says interests with Pershing, Ackman "aligned" on Allergan.
08:37 EDTAGNValeant says 'completely focused' on Allergan acquisition
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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).
08:08 EDTOREXOrexigen and Takeda announce availability of Contrave tablets for patients
Takeda Pharmaceutical, its wholly-owned subsidiary Takeda Pharmaceuticals U.S.A. and Orexigen Therapeutics jointly announced that Contrave extended-release tablets are now available to patients by prescription in pharmacies across the U.S.. Contrave is approved by the FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater, or 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition.
08:06 EDTSNY, MRKMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:47 EDTPFE, SHPGPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:34 EDTMRKAdvaxis names Mauro Chief Medical Officer
Advaxis (ADXS) announced that it has appointed David Mauro, as executive vice president, Chief Medical Officer Mauro most recently served as executive director, section head oncology clinical development at Merck (MRK). In connection with his appointment, Mauro received a one-time inducement award of 165K restricted shares, of which 55K are fully vested and as of the grant date. The remaining shares vest annually over a two-year period.
07:34 EDTAGNValeant says remains focused on completing Allergan transaction
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07:33 EDTSHPGShire upgraded to Buy from Neutral at SunTrust
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07:30 EDTAGNValeant CEO says 'can bid more than anyone' in financially sound Allergan deal
Pearson says "we cannot stop" another company from making a bid that does not make economic sense, but he believes Valeant (VRX) can "bid more than anyone" for Allergan (AGN) in a deal that makes financial sense. Pearson says he has met with doctor groups and that 95% of those he's spoken with support Valeant's bid for Allergan. Valeant CEO J. Michael Pearson spoke on CNBC.
07:19 EDTAMGN, MRK, SNY, SHPGIBC Life Sciences to hold a conference
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07:16 EDTAGN, SHPGAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
07:15 EDTPFE, SHPGAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFE, MRKAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFE, SNY, SHPGAmerican Society of Human Genetics to hold annual meeting
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07:04 EDTINFIInfinity Pharmaceuticals coverage resumed with a Hold at Stifel
07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
06:56 EDTSHPGShire reopens acquistion talks with NPS Pharmaceuticals, Cubist, Telegraph says
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06:28 EDTAGNAllergan price target raised to $210 from $190 at Citigroup
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05:29 EDTSHPGShire Interim CFO James Bowling to step down
Shire plc announces that James Bowling, Interim CFO, has notified the board of his decision to step down from his current role to pursue a new career opportunity as CFO of Severn Trent plc. James will leave Shire at the end of 1Q15 and the company will commence a search for a new CFO immediately.
October 19, 2014
15:56 EDTAMGNAmgen to aid in production method for Ebola drug ZMapp, Bloomberg says
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October 17, 2014
16:55 EDTJNJ, SHPGStocks 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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09:47 EDTAGNValeant will not raise Allergan bid ahead of record date, CNBC reports
Valeant (VRX) will not raise its hostile takeover bid for Allergan (AGN) ahead of the record date for the vote, CNBC's David Faber reports. Allergan (AGN) is not currently in takeover talks with Actavis (ACT), Faber added.
09:45 EDTAGNAllergan not in deal talks with Actavis, CNBC reports
09:43 EDTAGNValeant not going to raise Allergan bid ahead of meeting, CNBC reports
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09:06 EDTAMGN, SNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
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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07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
07:07 EDTSHPGShire may be buyer instead of target if AbbVie deal breaks, WSJ says
Assuming AbbVie's (ABBV) deal to buy Shire (SHPG) gets cancelled, which appears likely at this point, many analysts and investors believe Shire will become a buyer and Leerink Partners estimates the company could have $10B to use for a takeover deal, reported The Wall Street Journal. AbbVie will also be likely to look for other deals and could be forced to pay up for them, as its top seller, Humira, moves closer to losing patent exclusivity, the Journal said, citing analysts. Reference Link
October 16, 2014
16:29 EDTSHPGShire price target lowered to $198 from $278 at Leerink
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14:47 EDTJNJRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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12:42 EDTAGNAckman believes Allergan, Valeant merger likely, CNBC reports
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12:38 EDTAGNAckman says Allergan CEO manipulated Valeant shares, CNBC reports
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08:58 EDTAGNAllergan was pressured by AbbVie news, says BMO Capital
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08:52 EDTSHPGAbbVie price target lowered to $59 from $71 at BMO Capital
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08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:41 EDTINFIInfinity reports duvelisib Phase 2a primary endpoint not met
Infinity Pharmaceuticals announced encouraging topline data from its Phase 2a exploratory study of duvelisib, or IPI-145. Data from this randomized, double-blind, placebo-controlled, cross-over study demonstrated that duvelisib was well tolerated and met several secondary and exploratory endpoints in an allergen challenge study. Clinical improvement was observed in the late-phase asthmatic response FEV1 among patients who received duvelisib administered at the highest dose tested, 25 mg twice daily for five days, however the primary endpoint of the study was not met as it did not reach statistical significance. Multiple secondary clinical endpoints measuring improvements in lung function following duvelisib administration were achieved with statistical significance and were associated with changes in key cytokines and chemokines involved in the asthmatic response. Taken together, these data demonstrate early proof-of-activity in this allergen challenge study. Infinity expects to present the final data in a peer-reviewed setting after all analyses are complete. In addition, the company anticipates determining its next steps for development of PI3K-delta,gamma inhibitors in inflammation after evaluating the results from the ASPIRA study in rheumatoid arthritis, which are expected by the end of 2014.
07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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07:23 EDTAGNIBF Conferences to hold a summit
Ophthalmology Innovation Summit is being held in Chicago on October 16.
06:17 EDTSHPGJefferies says Medtronic 'needs to do' Covidien takeover
Jefferies says it "can't see how Medtronic walks" from the Covidien (COV) takeover given how compelling the merger is. The firm confirmed with Medtronic (MDT) that nothing has changed in the company's commitment to the deal since new financing terms were announced on October 3. In Jefferies view, "Medtronic needs to do this deal." It notes the spread on the acquisition widened significantly on the news that Abbvie (ABBV) is reconsidering its acquisition of Shire (SHPG).
05:50 EDTSHPGStocks with implied volatility movement; SHPG SIRI
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05:37 EDTSHPGShire releases statement regarding AbbVie withdrawal of recommendation
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05:21 EDTSHPGAbbVie recommends holders vote against Shire transaction
Following Shire's (SHPG) waiver of the three-day notice period, AbbVie (ABBV) announces its board withdraws its recommendation made on July 18 regarding the proposed Shire transaction and recommends that stockholders vote against the transaction. AbbVie and its board made this determination following a detailed consideration of the impact of the U.S. Department of Treasury's unilateral changes to the tax rules, as issued on September 22. The breadth and scope of the changes, including the unexpected nature of the exercise of administrative authority to impact longstanding tax principles, and to target specifically a subset of companies that would be treated differently than either other inverted companies or foreign domiciled entities, introduced an unacceptable level of uncertainty to the transaction. Additionally, the changes eliminated certain of the financial benefits of the transaction, most notably the ability to access current and future global cash flows in a tax efficient manner as originally contemplated in the transaction. This fundamentally changed the implied value of Shire to AbbVie in a significant manner. Under the conditions of AbbVie's offer and the terms of the Co-operation Agreement, the withdrawal of the recommendation alone will not cause a lapse of AbbVie's offer or terminate the Co-operation Agreement between AbbVie and Shire. Unless Shire and the U.K. Takeover Panel agree otherwise, AbbVie must convene an AbbVie stockholder meeting to consider the adoption of the U.S. merger agreement. AbbVie's offer will lapse if the company's stockholders do not adopt the agreement. Assuming Shire provides the requisite cooperation and consents, a pre-effective amendment to the registration statement filed by AbbVie Private Limited in connection with the combination is expected to be filed with the SEC as soon as practicable. Under the terms of the Co-operation Agreement, following the withdrawal of the AbbVie Board of Directors' recommendation, a break fee of approximately $1.64B will be payable to Shire if either: AbbVie stockholders do not approve the adoption of the U.S. merger agreement at an AbbVie stockholder meeting; or such a meeting does not occur by December 14.
October 15, 2014
17:17 EDTSHPGAbbVie, Shire both look like buys no matter what, Barron's says
AbbVie (ABBV) and Shire (SHPG) both offer great value and are buys even without a merger, Barron's argues in its 'Barron's Take' column. Reference Link
16:37 EDTSHPGOn The Fly: Closing Wrap
The market opened sharply lower amid sliding oil prices, worse than expected economic data, and the potential for a major M&A deal to fall apart due to tax inversion rule changes. The Dow fell more than 350 points within the first 30 minutes of trading, but then bounced back to move above its opening level. The volatility did not end there, however, as the market swung several more times during the session. The S&P 500's drop wiped out its gains for the year at one point, but a late day rally significantly cut the losses for the major averages. ECONOMIC EVENTS: In the U.S., retail sales, which were expected to be down 0.1% in September, actually fell 0.3% in the month and slipped 0.2% excluding autos. The Producer Price Index for final demand decreased a seasonally adjusted 0.1% in September from the prior month, marking the first decline in the measure in over a year. The core PPI reading, which excludes food and energy, was unchanged, versus expectations for a 0.1% rise. New York's Empire State manufacturing index fell 21.4 points to 6.2 in October, severely missing the expectation for a narrower pullback to a reading of 20. Business inventories rose 0.2% in August, versus expectations for an increase of 0.4%. In China, the consumer price index climbed 1.6% in September from a year earlier, which was below the consensus projection for 1.7% inflation and down from 2% inflation in August. China's PPI plunged 1.8% year-over-year in September, which was more than the 1.6% slide expected and an acceleration of the 1.2% year-on-year decline in August. COMPANY NEWS: Shares of Shire (SHPG) plunged $74.08, or 30.29%, to $170.49 after AbbVie's (ABBV) board last night stated that it was reconsidering its recommendation that the company's shareholders back a takeover of Irish drugmaker in light of the potential impact of tax rule changes on the deal. During the day, Bloomberg reported that people familiar with the matter say AbbVie is close to abandoning its $51B takeover bid, while Shire announced that it has agreed to waive the requirement for three business days' notice for AbbVie's board to meet to consider its offer. In contrast, AbbVie ended the session up 50c, or 0.92%, at $54.63... Wal-Mart (WMT) held its annual meeting, during which it lowered its fiscal year 2015 net sales growth forecast to 2%-3%, citing a tougher sales environment than it anticipated a year ago. The company indicated in February that it expected net sales growth to be at the low end of its guidance provided last October of 3%-5%. The world's largest retailer also cut its planned retail square foot growth expectations, due to a moderation of large format store growth and accelerated e-commerce investments. Following the outlook revisions, Wal-Mart closed down $2.78, or 3.57%, to $75.20. MAJOR MOVERS: Among the notable gainers was Penford Corporation (PENX), which jumped $7.60, or 69.15%, to $18.59 after the company agreed to be acquired by Ingredion (INGR) for $340M, or $19.00 in cash per share. Also higher was Southwestern Energy (SWN), which rose $2.59, or 7.82%, to $35.69 after it was among a number of oil and gas exploration and production names upgraded by analysts at Bank of America Merrill Lynch. Among the noteworthy losers was Nu Skin (NUS), which dropped $4.47, or 9.13%, to $44.50 after the company disclosed new debt arrangements that come with certain restrictions, including restrictions on the payment of dividends. Also lower were shares of Covidien (COV), which fell $6.50, or 7.04%, to $85.86 in the wake of the news for Shire and AbbVie, which investors may have read as jeopardizing Covidien's deal to be bought by Medtronic (MDT). Note that on October 3 Medtronic announced that it intends to use approximately $16B in external financing to complete the acquisition of Covidien and said the strategic benefits of the transaction "remain compelling" despite the additional expense of the new financing. INDEXES: The Dow dropped 173.45, or 1.06%, to 16,141.74, the Nasdaq slipped 11.85, or 0.28%, to 4,215.32, and the S&P 500 fell 15.21, or 0.81%, to 1,862.49.
15:00 EDTSHPG, AGN, PFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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13:45 EDTSHPGShire waives notice requirement for AbbVie board meeting
Shire (SHPG) announces that, in order to "allow the period of uncertainty for its shareholders, employees and other stakeholders to be reduced," it has agreed to waive the requirement for three business days' notice for AbbVie's (ABBV) board to meet to consider its recommendation of the offer for Shire.
13:19 EDTSHPGAbbVie close to dropping takeover bid for Shire, Bloomberg reports
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13:07 EDTAGNAllergan seeing arb-related selling pressure, says BMO Capital
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12:59 EDTSHPGShire at lows down 33% after Bloomberg says AbbVie close to dropping bid
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12:58 EDTSHPGAbbVie close to dropping takeover bid for Shire, Bloomberg reports
12:42 EDTMRKNY AG announces $31M Medicaid settlement with Organon
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12:36 EDTSHPGOn The Fly: Midday Wrap
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10:48 EDTSHPGShire tanks with AbbVie calling board meeting over merger
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10:02 EDTSHPG, SNYOn The Fly: Analyst Upgrade Summary
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09:57 EDTJNJ, MRKLeerink biotech analysts hold an analyst/industry conference call
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09:38 EDTJNJActive equity options trading on open
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09:20 EDTSHPGOn The Fly: Pre-market Movers
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09:15 EDTJNJJ&J comments positive for Anika Therapeutics, says Summer Street
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09:11 EDTSHPGShire upgraded to Buy from Fair Value at CRT Capital
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08:35 EDTOREXOrexigen earned $60M milestone payment from Takeda Pharmaceutical
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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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07:30 EDTSHPGAbbVie review of Shire deal an 'unwelcome surprise,' says Jefferies
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07:29 EDTSNYSelecta, JDRF, Sanofi extend collaboration for SVP immunotherapy
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07:14 EDTJNJJohnson & Johnson price target lowered to $110-$111 from $119-$120 at Wells Fargo
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06:58 EDTSHPGAbbVie volatility elevated into reconsidering Shire merger
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06:55 EDTSHPGShire volatility elevated into AbbVie reconsidering merger recommendation
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05:34 EDTSHPGShire says AbbVie should proceed with recommended offer
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05:26 EDTSNYSanofi upgraded to Outperform from Neutral at Credit Suisse
October 14, 2014
19:50 EDTSHPGShire down nearly 6% following AbbVie reconsidering merger recommendation
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19:48 EDTSHPGAbbVie board reconsidering recommendation to holders to accept Shire merger
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19:46 EDTSHPGAbbVie board reconsidering recommendation to holders to accept Shire merger
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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 EDTJNJ, SNY, NVO, PFE, AMGN, MRKBIND 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.
09:00 EDTSNYSanofi rotavirus vaccine enters Phase III trials in India
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08:58 EDTJNJJ&J sees FY14 operating sales on constant currency basis up 5.5%-6.5%
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08:08 EDTSNYRegulus Therapeutics to present new preclinical data on multiple programs
Regulus Therapeutics (RGLS) announced that it will present new preclinical data on multiple programs and an overview of its clinical portfolio at the 10th Annual Oligonucleotide Therapeutics Society meeting being held October 12-October 15 at the Hilton San Diego Resort and Spa. In a poster titled "Anti-Diabetic Activity of miR-103/107 Anti-miRs", Regulus scientists will present preclinical data further demonstrating the potential benefit of a microRNA therapeutic for the treatment of metabolic disorders. In a poster titled "Inhibition of miR-21 with RG-012 Improves Renal Function and Survival in Multiple Strains of Col4A3 Deficient Mice", Regulus scientists, in collaboration with its strategic alliance partner Sanofi (SNY), will present new preclinical data demonstrating that weekly subcutaneous delivery of RG-012 has shown to provide both glomerular and tubule protection in the kidneys of Col4A3 deficient mice in an Alport syndrome model.
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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06:03 EDTAGNMarket overreacted to new Irish tax rules, says BMO Capital
BMO Capital believes the market may have overreacted yesterday to the report that Ireland is eliminating the "Double Irish" tax loophole. The firm says Allergan (AGN) confirmed that it incorporated potential changes to Irish tax law in its recently raised earnings guidance while Mallinckrodt (MNK) said it does expect the new tax structure to have an immediate impact. BMO views yesterday's pullback in shares of Allergan, Mallinckrodt and Actavis (ACT) as an overreaction.
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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13:05 EDTINFIInfinity Pharmaceuticals management to meet with ISI Group
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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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07:37 EDTMRKAmerican Society of Anesthesiologists to hold annual meeting
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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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06:39 EDTAGNAllergan takeout value at or above $210 per share, says Leerink
Leerink believes Allergan's takeover value is now at or above $210 per share given the company's recent execution. After speaking with management, the firm says Allergan's upside in Q3 was driving by fundamentals, not cost cuts. It continues to view the "most likely and straightforward outcome" for Allergan as being an outright sale of the company. Leerink raised its price target for shares to $215 from $184 and keeps an Outperform rating on Allergan.
October 10, 2014
17:14 EDTAGNMarket ends week lower amid global growth worries
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10:20 EDTAGNFidelity supports potential merger between Actavis and Allergan, Reuters reports
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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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07:37 EDTAGNActavis more likely partner than Valeant if Allergan merges, says UBS
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07:35 EDTAGNAllergan price target raised to $224-$225, from $198-$199 at Wells Fargo
Wells Fargo increased its price target on Allergan after the company pre-released better-than-expected revenue and EPS, and raised its 2014-2016 EPS guidance. The firm keeps an Outperform rating on the shares.
07:16 EDTAGNAmerican Society of Plastic Surgeons to hold annual meeting
Annual Meeting of ASPS is being held in Chicago on October 10-14.
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
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