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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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July 31, 2015
16:22 EDTMRK, PFEStocks end week higher in U.S. despite selloff in China
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13:19 EDTMRKNewLink Ebola results promising, says Mizuho
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09:56 EDTPFEOptions with increasing volume on open
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08:24 EDTMRKNewLink Genetics announces data suggesting efficacy of Ebola vaccine
NewLink Genetics (NLNK) announced that the international partnership studying the VSV-ZEBOV Ebola vaccine candidate in Guinea has released interim data suggesting that it is effective against Ebola in a large clinical trial. Interim results suggest that the vaccine candidate demonstrates efficacy within about 10 days of administration to a person without the infection. The VSV-ZEBOV Ebola vaccine candidate was originally developed by the Public Health Agency of Canada, and was subsequently licensed to a subsidiary of NewLink Genetics. In late 2014, Merck (MRK) licensed the vaccine from NewLink Genetics to apply Merck’s vaccine expertise to help accelerate the development of this promising candidate. Merck is now responsible for research, development and manufacturing of the rVSV-ZEBOV vaccine.
08:13 EDTMRKMerck: Investigational ebola vaccine had 100% efficacy in study analysis
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07:27 EDTJNJJohnson & Johnson drug business likely to remain resilient, says Wells Fargo
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July 30, 2015
11:02 EDTABTAbbott to purchase Tendyne Holdings, Cephea Valve Technologies
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09:01 EDTSNYLigand enters license, supply agreement with Sanofi
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07:26 EDTSNYSanofi backs view of FY15 business EPS to be stable to slightly growing
Sanofi said performance of the second quarter is in line with the full year guidance announced on February 5. Sanofi expects 2015 Business EPS to be stable to slightly growing versus 2014 at constant average exchange rates, barring major unforeseen adverse events. In addition, the positive currency impact on 2015 full-year business EPS is estimated to be approximately +10%, under the assumption that exchange rates remain stable in the following two quarters at the average rates of June.
07:25 EDTSNYSanofi reports Q2 business EPS increased 5.1% at CER to EUR1.41
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July 29, 2015
20:10 EDTCELGCelgene says patent challenges are baseless, Reuters reports
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19:08 EDTBMYBristol-Myers enters immuno-oncology collaboration with Kyowa Hakko Kirin
Kyowa Hakko Kirin and Bristol-Myers Squibb announced that the companies have entered into a clinical trial collaboration agreement to conduct a Phase 1/2 combination study with mogamulizumab, an anti-CCR4 antibody and Opdivo, a PD-1 immune checkpoint inhibitor. The study, which will be conducted in the U.S., will focus on evaluating the safety, tolerability and anti-tumor activity of combining mogamulizumab and Opdivo as a potential treatment option for patients with advanced or metastatic solid tumors. Prior to this agreement, Kyowa Hakko Kirin, Bristol-Myers Squibb and Ono Pharmaceutical entered into a clinical trial collaboration agreement to study the combination of mogamulizumab and Opdivo in Japan. Mogamulizumab and Opdivo are 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.
14:49 EDTGSKGlaxoSmithKline probing new bribery allegations in Romania, Reuters reports
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12:17 EDTJNJMedivation plummets after Cowen highlights slowing Xtandi trends
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11:23 EDTJNJMedivir says Janssen's Alios BIopharma starts Phase I AL-704 trial
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09:20 EDTMRKMerck recent weakness creates buying opportunity, says Argus
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08:00 EDTGSKGlaxoSmithKline reports Q2 global pharmaceuticals revenue GBP2.98B, down 12%
Reports Q2 HIV revenue GBP559M, up 59%. Reports Q2 Pharmaceuticals revenue GBP3.54B, down 6%, and vaccines revenue GBP814M, up 11%. Consumer healthcare sales were GBP1.51B, up 51% year over year.
07:58 EDTGSKGlaxoSmithKline sees FY16 core EPS to grow in double digits
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07:57 EDTGSKGlaxoSmithKline reaffirms FY15 core EPS declining at high-teens percentage rate
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07:54 EDTGSKGlaxoSmithKline reports Q2 adjusted EPS 17.3p, consensus 16.78p
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07:20 EDTSNYSanofi's LixiLan meets Phase 3 primary endpoint for diabetes
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06:50 EDTPFEPfizer CEO: Company has 'sufficient courage' to pursue takeovers, FT says
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05:28 EDTNVSNovartis announces equity stake in Mereo BioPharma Group
Novartis announced a swap of clinical assets for equity with Mereo BioPharma Group. The deal involves compounds in areas of unmet medical need including BPS-804, to improve bone density in brittle bone syndrome, an orphan disease; BCT-197 for acute exacerbations in COPD, and BGS-649 for obese men with hypogonadotrophic hypogonadism to normalize testosterone levels. Under the terms of the agreement, Novartis will have an equity stake in Mereo and will share in the success of the development of these compounds, including a share on milestones and royalties on future commercial sales.
July 28, 2015
16:53 EDTPFE, MRKOn The Fly: Top stock stories for Tuesday
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12:31 EDTMRK, PFEOn The Fly: Top stock stories at midday
Stocks on Wall Street began the session in positive territory but turned mixed a short time after the open. The averages gathered themselves again and began an upward drift about an hour into trading, leaving markets near session highs around noon as stocks try to break their string of five consecutive lower closes. ECONOMIC EVENTS: In the U.S., the Case Shiller 20-city home price index rose 1.1% in May to 179.03, missing a forecast for it to rise 1.7% to 180.2. Markit's services PMI for July rose to 55.2, above the expected 55.0 reading. The Richmond Fed factory index rose to 13.0 in July from an upwardly revised 7 in June. Consumer confidence fell to 90.9 in July, down from a revised 99.8 figure for last month and below the expected reading of 100. In China, the Shanghai composite index closed down 1.7%, but only after a volatile session that saw it down as much as 5.1% and up about 1% at different points in the trading day. In Europe, U.K. GDP growth in the second quarter came in at 0.7%, matching the consensus expectation. COMPANY NEWS: Earnings season continued in earnest with UPS (UPS), Ford (F), Pfizer (PFE) and Merck (MRK) each reporting better than expected quarterly profits. UPS, which said its quarterly results gave it confidence in achieving the upper end of its earnings guidance range for the fiscal year, rose more than 5%. Pfizer and Merck each raised their fiscal year earnings guidance ranges, but Pfizer advanced 1.7% following its report while Merck slid nearly 0.5%. Ford, meanwhile, gained 1.8% after backing its fiscal year pre-tax profit view and repeating that it still expects the second half of the year to be stronger than the first half. MAJOR MOVERS: Among the notable gainers was Supervalu (SVU), which jumped 19% after the company reported better than expected first quarter results and also announced that it is exploring a separation of its Save-A-Lot business into a stand-alone, publicly traded company. Also higher was GrubHub (GRUB), which gained over 5% after reporting better than expect top and bottom line results in its second quarter and issuing 2015 guidance that analysts at Stifel said "appears conservative." Among the noteworthy losers was Immunomedics (IMMU), which tumbled 34% after the company's partner, UCB, announced that two Phase 3 clinical studies for epratuzumab in Systemic Lupus Erythematosus did not meet their primary clinical efficacy endpoints in either dose in both studies. Also lower following its earnings reports was Baidu (BIDU), which fell 16.5% and was downgraded by at least four research firms. INDEXES: Near midday, the Dow was up 136.13, or 0.78%, to 17,576.72, the Nasdaq was up 36.37, or 0.72%, to 5,076.14, and the S&P 500 was up 19.42, or 0.94%, to 2,087.06.
09:28 EDTSNYRegeneron buyout talk to renew after collaboration, says Roth Capital
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07:40 EDTSNYRegeneron cancer deal could be major value driver, says RBC Capital
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07:31 EDTCELGCelgene commences tender offer for Receptos
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07:20 EDTMRK, BMY, PFEBrookings Institute to hold a public meeting
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07:18 EDTPFEPfizer raises FY15 adjusted EPS view to $2.01-$2.07, consensus $2.04
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07:17 EDTPFEPfizer reports Q2 innovative products revenue $6.63B, up 8%
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07:11 EDTMRKMerck reports Q2 Pharmaceutical sales $8.56B
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07:05 EDTJNJMacroGenics reports MGD011 advances into clinical development
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07:04 EDTMRKMerck narrows FY15 EPS view to $3.45-$3.55, consensus $3.45
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07:03 EDTMRKMerck reports Q2 EPS 86c, consensus 81c
Reports Q2 revenue $9.8B, consensus $9.8B.
07:02 EDTPFEPfizer reports Q2 EPS adjusted 56c, consensus 52c
Reports Q2 revenue $11.9B, consensus $11.42B.
06:49 EDTMRKMerck to acquire cCam Biotherapeutics for $95M
Merck and cCAM Biotherapeutics announced that the companies have signed a definitive agreement under which Merck will acquire cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95M in cash. In addition, cCAM shareholders of record are eligible to receive a total of up to $510M associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions.
06:32 EDTMRKMerck's grazoprevir/elbasvir application accepted by FDA
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05:27 EDTSNYRegeneron, Sanofi launch immuno-oncology collaboration
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July 27, 2015
18:30 EDTPFEAllergan CEO pursuing 'transformational deals,' FT says
In a Financial Times interview following the sale of its generics unit to Teva (TEVA), Allergan's (AGN) CEO Brent Saunders stated, "We’re going to contemplate transformational deals... We couldn’t before because of our capital structure and debt, but now we can." When asked about the timing of a potential deal, Saunders remarked, "We’re not going to plod along," and when asked about a hypothetical takeover by Pfizer (PFE), the CEO commented, "I spend zero time thinking about Pfizer and I am not doing anything to make us more or less attractive to them." Reference Link
17:31 EDTGSKRadius Health hires Dr. Lorraine Fitzpatrick as Chief Medical Officer
Radius Health (RDUS) announced that it has hired Dr. Lorraine A. Fitzpatrick as Chief Medical Officer of the Company. Dr. Fitzpatrick was previously Medicine Development Leader of an international clinical development team for Denosumab at GlaxoSmithKline (GSK), responsible for clinical development, regulatory, manufacturing, commercial, operations, epidemiology, and global health outcomes. Previously, Dr. Fitzpatrick led the clinical development of novel agents to treat musculoskeletal diseases and women's health at GlaxoSmithKline. Before joining GlaxoSmithKline, Dr. Fitzpatrick was Executive Director at Amgen, Inc. where she worked in the fields of osteoporosis and oncology.
16:00 EDTPFEOptions Update; July 27, 2015
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15:03 EDTMRK, PFENotable companies reporting before tomorrow's open
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14:43 EDTMRKEarnings Watch: Merck's Keytruda sales will be focus in Q2 results
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12:36 EDTPFEEarnings Watch: Pfizer shares nearly flat since last earnings report
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10:40 EDTCELGIsis 'most obvious' Biogen takeover target, TheStreet's Feuerstein says
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10:40 EDTJNJLeerink major pharma analyst holds an analyst/industry conference call
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08:38 EDTCELGAnalysts divided on Biogen following $85 selloff
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08:32 EDTMRKMerck receives 'positive' CHMP opinion for Zerbaxa
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08:22 EDTSNYNews reports on Regeneron Praluent label inaccurate, says RBC Capital
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08:05 EDTSNYAlnylam initiates Phase 1/2 clinical trial for ALN-AAT
Alnylam Pharmaceuticals (ALNY) has initiated a Phase 1/2 clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin for the treatment of AAT deficiency-associated liver disease. The Phase 1/2 trial will be conducted initially in normal healthy volunteers, and, then, in patients with alpha-1 liver disease. Initiation of this trial is based on encouraging pre-clinical data presented at the Digestive Disease Week meeting May 16 – 19, 2015. The company expects to present initial clinical data from this trial in early 2016. ALN-AAT is a subcutaneously administered investigational RNAi therapeutic that utilizes Alnylam’s proprietary ESC-GalNAc-siRNA conjugate delivery technology. ESC-GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor, and enable subcutaneous dosing with increased potency and durability and a wide therapeutic index. As per the filed CTA, the Phase 1/2 trial of ALN-AAT is a randomized, single-blind, placebo-controlled study being conducted in three parts. Parts A and B are single-dose and multi-dose, dose-escalation studies, designed to enroll up to a total of 48 healthy adult volunteers. Part C will be a multi-dose study designed to enroll up to a total of 24 adults with alpha-1 liver disease and mild-to-moderate liver fibrosis. The primary objective of the study is to evaluate safety and tolerability of single and multiple subcutaneous doses of ALN-AAT. Secondary objectives include evaluation of pharmacokinetics and clinical activity for ALN-AAT as measured by knockdown of serum AAT. In addition, biopsies will be obtained from subjects with alpha-1 liver disease to quantify the effects of treatment on levels of periodic acid-Schiff-stained globules, a measure of misfolded AAT accumulation observed in the livers of alpha-1 liver disease patients. In January 2014, Alnylam and Genzyme, a Sanofi (SNY) company, formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in North America and Western Europe, while Genzyme obtained the right to access certain programs in Alnylam's current and future Genetic Medicines pipeline, including ALN-AAT, in the rest of the world. In certain defined instances, Genzyme has co-development/co-commercialization and/or global product rights. Genzyme's rights are structured as an opt-in that is triggered upon achievement of human proof-of-principle.
08:03 EDTGSKNephroGenex names Jaikrishna Patel as Chief Medical Officer
NephroGenex (NRX) announced the appointment of Dr. Jaikrishna Patel to the position of Chief Medical Officer. Dr. Patel will help guide the company’s Phase 3 PIONEER program with oral Pyridorin for the treatment of diabetic nephropathy, and the development of an intravenous formulation of Pyridorin for acute kidney injury. Patel has held numerous positions of increasing responsibility at GlaxoSmithKline (GSK) and its predecessor companies, most recently serving as Vice President of Cardiovascular and Cardiovascular Metabolism, Global Regulatory Affairs.
07:40 EDTSNYEsperion price target lowered to $120 from $130 at Citi
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07:37 EDTMRKAeterna Zentaris starts promoting Saizen for injection in 25 U.S. territories
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07:01 EDTBMYBristol-Myers, AbbVie say EMA validates for review Empliciti MAA
Bristol-Myers Squibb Company (BMY) and AbbVie (ABBV) announced the European Medicines Agency validated for review the Marketing Authorization Application for Empliciti, an investigational Signaling Lymphocyte Activation Molecule-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies. The application was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use. Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health authorities, will serve as the trade name for elotuzumab. The MAA is primarily supported by data from two randomized clinical trials, each combining Empliciti with a different standard of care regimen for multiple myeloma. ELOQUENT-2, a Phase 3, randomized, open-label study, evaluated Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial were published in The New England Journal of Medicine on June 2. Additionally, a Phase 2, randomized, open-label study evaluated Empliciti with bortezomib and dexamethasone versus bortezomib and dexamethasone alone. These Phase 2 results were presented in an oral session at the 20th Congress of the European Hematology Association. Empliciti previously obtained orphan drug designation in the European Union. An orphan medicinal product must be intended for the treatment, prevention or diagnosis of a disease that is life threatening and chronically debilitating; the prevalence in the EU must not be more than five in 10,000. The medicine must be of significant benefit to those affected by the condition. If maintained, orphan drug designation allows sponsors to access a number of incentives including protocol assistance and receive market exclusivity for a ten-year period following approval.
05:25 EDTSNYGenzyme acquires Caprelsa from AstraZeneca for $300M
Genzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.
July 24, 2015
16:00 EDTSNYRegeneron, Sanofi say the U.S. WAC price of Praluent is $40 per day
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15:27 EDTSNYEsperion likely to stay pressured until path for ETC-1002 clearer, says Barclays
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15:25 EDTSNYRegeneron, Sanofi's cholesterol treatment Praluent gets FDA approval
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration approved Praluent Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Praluent is the first and only PCSK9 inhibitor approved in the U.S. and is available in two different doses- 75 mg and 150 mg. Both doses of Praluent are available in a single 1 milliliter injection delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks. The companies carefully considered the potential medical value that Praluent offers patients in determining the Wholesale Acquisition Cost. The U.S. WAC price of Praluent is $40 per day, $1,120 every 28 days, for both the 75 mg and 150 mg doses, making Praluent the lowest priced patient-administered monoclonal antibody therapy on an annualized basis. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.
14:44 EDTSNYEsperion slides after FDA assigns indication for rival cholesterol drug
Shares of Esperion Therapeutics (ESPR), a drug company focused on LDL-cholesterol lowering therapies, are sharply lower in afternoon trading after the FDA granted approval for the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. WHAT'S NEW: This afternoon, the FDA announced the approval of Praluent injection, which is a PCSK9 drug marketed by Sanofi (SNY) and Regeneron (REGN). Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol, the FDA indicated. The drug, like Esperion's ETC-1002, seeks to lower patients' cholesterol. PRICE ACTION: In afternoon trading, Esperion shares are down 12% to $84.21. The stock spiked as low as $81.50 immediately after the FDA made its announcement regarding Praulent. Meanwhile, Sanofi shares are fractionally higher and Regeneron shares are halted.
14:20 EDTSNYSanofi drops 0.4% to $53.32 after FDA makes announcement on Praluent
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14:20 EDTSNYFDA approves Regeneron, Sanofi cholesterol-lowering treatment
The announced the approval of Praluent injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Praluent is marketed by Sanofi-Aventis (SNY) and Regeneron (REGN). Shares of Regeneron remain halted.
14:08 EDTBMYBristol-Myers confirms FDA approval of hepatitis drug Daklinza
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13:49 EDTBMYFDA approves new treatment for chronic hepatitis C genotype 3
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11:02 EDTBMYBristol-Myers selects Jones Lang LaSalle for facility management
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10:56 EDTNVSNovartis announces FDA approval of Odomzo
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09:02 EDTNVSLigand says Revolade recommended by CHMP for EU approval for SAA
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08:08 EDTCELGCelgene price target raised to $190 from $156 at Canaccord
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07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:17 EDTNVSNovartis combination therapy Tafinlar, Mekinist achieves regulatory milestones
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07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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05:04 EDTGSKAgenus reports GSK Malaria vaccine receives positive opinion from CHMP of EMA
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July 23, 2015
19:50 EDTCELGCelgene price target raised to $163 from $146 at Cantor
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18:21 EDTBMYOn The Fly: Top stock stories for Thursday
Stocks began the session mixed on the heels of weak earnings reports from both Caterpillar (CAT) and 3M (MMM). The Nasdaq managed to spend most of the day in positive territory but joined the other averages in negative territory by mid-afternoon. Selling picked up momentum towards late afternoon, and by day’s end each of the averages were lower by more than 0.4%, with the Dow losing nearly 0.7%. ECONOMIC EVENTS: In the U.S., initial jobless claims fell to 255,000 in the week ended July 18, below the 278,000 first-time claims that were expected. The Leading Economic Indicators advanced 0.6% in June, exceeding expectations for a 0.3% increase. In Asia, the Shanghai Composite index advanced for a sixth straight session, adding another 2.4%. In Europe, the Greek Parliament voted to accept creditor terms for a new bailout, though a decision on when to reopen Greek financial markets was deferred to next week. COMPANY NEWS: Shares of General Motors (GM) finished the session up 3.96% to $31.50 after reporting earnings per share above analyst expectations. Other notable names rising following earnings reports include SanDisk (SNDK), Under Armour (UA), Southwest (LUV)... Caterpillar, meanwhile, dropped $2.86, or 3.59%, to $76.90 after cutting its yearly guidance during this morning's earnings report, with the company noting a "relatively stagnant" global economy. Also lower following earnings were Comcast (CMCSA, CMCSK), Bristol-Myers Squibb (BMY), Dunkin Brands (DNKN), and Boston Scientific (BSX). MAJOR MOVERS: Among the notable gainers was Cigna (CI), which rose $3.29, or 2.18%, to $154.36 after the Wall Street Journal reported last night that Anthem (ANTM) is nearing a deal to acquire the company for roughly $187, representing a total transaction value of over $48B. Adding to that report, CNBC's David Faber said on Thursday morning that Anthem will announce an agreement Friday to purchase Cigna for $188 per share, at a 45% equity, 55% cash split. Also higher were shares of numerous IT security companies, with FireEye (FEYE) advancing 4.53% and Palo Alto Networks (PANW) adding 2.33% after earnings reports from security firms Fortinet (FTNT) and F5 Networks (FFIV) beat on both top and bottom lines. Fortinet and F5, meanwhile, finished Thursday's session up 10.71% and 7.75% to $46.83 and $127.68, respectively. Among the noteworthy losers following earnings was McDonald's (MCD), which edged down 0.52% to $97.10 after noting that Q2 global comparable sales fell 0.7% for the quarter, including a 2% decline in U.S. same-store sales. Also lower was Hertz (HTZ), which declined 8.53% to $16.45 following a downgrade to Underweight at Morgan Stanley, with the research firm citing increased competition from Uber and similar mobility services. INDEXES: The Dow fell 119.12, or 0.67%, to 17,731.92, the Nasdaq lost 25.36, or 0.49%, to 5,146.41, and the S&P 500 declined 12.00, or 0.57%, to 2,102.15.
17:51 EDTJNJJanssen submits sNDA to update label for Olysio
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14:01 EDTSHPGShire receives 'positive opinion' on Intuniv from CHMP
Shire announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv, or guanfacine hydrochloride extended release, for the treatment of attention deficit/hyperactivity disorder in children and adolescents. The positive opinion is based on results from three Phase 3 pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents. The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe, said Shire.
11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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10:50 EDTCELGCelgene positioned for sustainable growth, says Piper Jaffray
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07:37 EDTCELGCelgene reports Q2 Revlimid sales up 19% to $1.44B
ABRAXANE® sales for the second quarter were $244 million, a 13 percent increase. POMALYST®/IMNOVID® sales for the second quarter were $235 million, an increase of 46%. VIDAZA® sales in the second quarter remained flat year-over-year at $152 million. OTEZLA® sales for the second quarter were $90 million, increasing 49 percent over the first quarter of 2015.
07:37 EDTCELGCelgene raises FY15 adjusted EPS view to $4.75-$4.85 from $4.60-$4.75
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07:34 EDTBMYBristol-Myers raises FY15 adjusted EPS view to $1.70-$1.80 from $1.60-$1.70
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07:32 EDTCELGCelgene reports Q2 adjusted EPS $1.23, consensus $1.20
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07:31 EDTBMYBristol-Myers reports Q2 EPS 53c, consensus 36c
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07:25 EDTSHPGShire raises FY15 EPADS growth view to mid-to-high single digit percentage
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07:22 EDTSHPGShire reports Q2 EPS $2.63, consensus $2.81
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06:38 EDTBMYBristol-Myers' two Opdivo applications validated by European Medicines Agency
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July 22, 2015
15:26 EDTBMY, CELGNotable companies reporting before tomorrow's open
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10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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10:06 EDTABTAbbott CEO says supportive of Mylan pursuit of Perrigo
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09:33 EDTABTAbbott sees Q3 Diagnostics sales up mid single digits on operational basis
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09:30 EDTABTAbbott CEO says 'pretty alligned' with Mylan so far
09:28 EDTCELGBiogen downgraded to Neutral at Piper Jaffray after Alzheimer's data
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09:15 EDTABTAbbott sees FY15 reported sales growth to be in low single digits
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09:15 EDTABTAbbott sees Q3 EPS 52c-54c, consensus 55c
Sees Q3 impact from foreign exchange to be "somewhat above" 9% based on current exchange rates, resulting in reported sales growth in the low single digits, consensus $5.19B. Guidance from Q2 earnings call.
09:07 EDTABTOn The Fly: Pre-market Movers
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09:07 EDTABTAbbott says foreign exchange impacting results more than expected in January
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08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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07:49 EDTABTAbbott reports Q2 Nutrition sales $1.72B, Diagnostics sales $1.18B
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07:48 EDTABTAbbott backs FY15 adjusted EPS $2.10-$2.20, consensus $2.16
Abbott forecasts net specified items related to continuing operations for the full year 2015 of approximately 60c per share.
07:47 EDTABTAbbott reports Q2 adjusted EPS 52c, consensus 50c
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07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
07:03 EDTNVSIgnyta names Bernard Parker as Chief Commercial Officer
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06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
15:02 EDTABTNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include Coca-Cola (KO), consensus 60c... Boeing (BA), consensus $1.42... Abbott Laboratories (ABT), consensus 50c... Thermo Fisher Scientific (TMO), consensus $1.78... EMC (EMC), consensus 41c... Illinois Tool Works (ITW), consensus $1.28... St. Jude Medical (STJ), consensus $1.00... Northern Trust (NTRS), consensus 96c... Check Point Software (CHKP), consensus 95c... Polaris Industries (PII), consensus $1.58... Interpublic Group (IPG), consensus 27c... New York Community Bancorp (NYCB), consensus 26c... B/E Aerospace (BEAV), consensus 76c... Owens Corning (OC), consensus 54c... Knight Transportation (KNX), consensus 37c.
14:03 EDTBMYBristol-Myers: Data from Phase IIa study support further evaluation of BMS955176
Bristol-Myers Squibb announced additional Phase IIa proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings, which are being presented in a late-breaking oral presentation at the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir and support further development of the second-generation HIV-1 maturation inhibitor. BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral lifecycle, resulting in the release of immature non-infectious HIV-1 particles. As part of a multi-part proof-of-concept study, a two-drug combination of BMS-955176 plus atazanavir had a maximum median change in HIV-1 RNA of -2.23 log10 c/mL from baseline through study discharge. The standard of care control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log10 c/mL from baseline through study discharge. In addition, a lower dose of BMS-955176 plus atazanavir and ritonavir had a similar maximum median change in HIV-1 RNA of -2.20 log10 c/mL. Length of therapy for all treatment groups was 28 days. Study endpoints included change in HIV-1 RNA from baseline to Day 28 and from baseline to the end of the study and safety. Data from Part A and Part B of the Phase IIa proof-of-concept study support the further evaluation of BMS-955176 in novel treatment regimens such as nucleos(t)ide- and booster-sparing regimens to address key unmet needs for HIV-1 treatment-experienced patients. Two Phase IIb studies have started in 2015: a traditional dose-finding study in treatment-naive patients and a second Phase IIb study to evaluate a nucleos(t)ide- and booster-sparing regimen in treatment-experienced patients.
12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
11:49 EDTNVSNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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11:03 EDTCELGCelgene treatment of pediatric Crohn's disease receives FDA orphan designation
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09:02 EDTBMYBristol-Myers Squibb receives FDA breakthrough designation for HIV-1 inhibitor
Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral, or ARV, agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
06:29 EDTCELGCelgene price target raised to $160 from $147 at Piper Jaffray
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06:24 EDTCELGPiper expects 'stronger, bolder' move from Biogen
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05:20 EDTNVSNovartis backs FY15 revenue guidance of up mid-single digit
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05:17 EDTNVSNovartis reports Q2 core EPS $1.27, consensus $1.24
Reports Q2 revenue $12.7B, consensus $12.44B. Further strengthening of USD impacted sales by -11% and core operating income by -13%. Growth Products, an indicator of the rejuvenation of the portfolio, contributed 35% of continuing operations net sales in Q2, and were up 24%. In Pharmaceuticals, Growth Products contributed 44% of division net sales in the quarter, and sales for these products were up 38%.
July 20, 2015
12:09 EDTBMYBristol-Myers says Nivolumab BMS approved in EU for SQ NSCLC
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12:08 EDTBMYOn The Fly: Top stock stories at midday
Stocks on Wall Street were slightly higher at midday in the first trading day of a week that will be light on domestic economic data but heavy on earnings reports. Investors will be receiving profit reports from about 25% of the companies on the S&P 500 this week, making this the highest volume earnings week of this season. ECONOMIC EVENTS: In the U.S., no major data was released. In Europe, Greece reopened its banks three weeks after closing as the country worked out another bailout agreement. The country announced it has started the process of paying off its creditors, including the European Central Bank and the International Monetary Fund, with a bridge loan it just received. COMPANY NEWS: Lockheed Martin (LMT) agreed to buy the Sikorsky Aircraft business from United Technologies (UTX) for $9B, noting the price is "effectively reduced" to $7.1B after taking into account tax benefits resulting from the transaction. Shares of Lockheed, which also reported better than expected second quarter results and increased its fiscal year guidance, gained nearly 2% after the Sikorsky announcement and saying it will conduct a strategic review of its government IT infrastructure services business and technical services business... Shares of Morgan Stanley (MS) shares were little changed near noon after the bank reported earnings and revenue, excluding certain adjustments, that topped analysts' consensus forecasts... SunEdison (SUNE) announced a deal to acquire Vivint Solar (VSLR) for approximately $2.2B, payable in a combination of cash, shares of SunEdison common stock and SunEdison convertible notes. In connection with the proposed acquisition of Vivint Solar, SunEdison has entered into a definitive purchase agreement with a subsidiary of TerraForm Power (TERP) which, concurrently with the completion of SunEdison's acquisition of Vivint, will acquire Vivint Solar's rooftop solar portfolio, consisting of 523 MW expected to be installed by year-end 2015, for $922M in cash. Shares of Vivint rose 44% following the announcement, while SunEdison's stock gained 4% and TerraForm dropped 3%. Fellow residential solar installer SolarCity (SCTY), which is backed by Tesla's (TSLA) Elon Musk, rose 7% following the deal in the space. MAJOR MOVERS: Among the notable gainers was Exelixis (EXEL), which rallied 43% after the company reported that a study of cabozantinib in metastatic renal cell carcinoma met its primary endpoint of significant improvement in progression-free survival. The shares were indicated to rise even more in early pre-market trading, but lost some of their gains after Bristol-Myers (BMY) announced that its Opdivo study was stopped early after showing superior overall survival in a Phase 3 study of previously treated patients with advanced or metastatic renal cell carcinoma. Bristol-Myers rose a bit less than 1% to trade near $70 per share after its own announcement. Also higher was PayPal (PYPL), which gained more than 5.5% in its first day of trading after being spun out of eBay (EBAY). Meanwhile, eBay shares rose over 2%. Cal-Maine Foods (CALM) dropped 8% after posting lower than expected sales and profits in its fourth quarter and warning that while it should have an adequate supply of its primary feed ingredients, the company expects that prices will be "volatile" in the year ahead. Also lower were shares of several gold miners, including Barrick Gold (ABX) and Newmont Mining (NEM), which each fell about 11%, as gold prices declined about 2% near midday. INDEXES: Near midday, the Dow was up 31.66, or 0.18%, to 18,118.11, the Nasdaq was up 9.81, or 0.19%, to 5,219.96, and the S&P 500 was up 2.82, or 0.13%, to 2,129.46.
09:02 EDTABTAbbott receives FDA approval and launches iDesign Advanced WaveScan system
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08:38 EDTABTAnalyst predicts Zoetis merges with Bayer unit, not Valeant
Zoetis (ZTS) in recent months has been the subject of takeover speculation, possibly for Valeant (VRX), but a Jefferies analyst told investors today in a research note that he views a deal with a unit of healthcare giant Bayer (BAYRY) as "highly likely" for the animal medicine company. BACKGROUND: Bill Ackman of Pershing Square, who owns stakes in both Zoetis and Valeant, said in early May while speaking on CNBC that Zoetis is a "great” business on a standalone basis, but he also spoke of the company's strategic value. Ackman added, however, that he was "not sure" that Valeant was the best acquirer of Zoetis. Subsequently, in late June, The Wall Street Journal reported that Valeant made a preliminary approach regarding a potential deal to buy Zoetis. CNBC's David Faber said the next day, citing his own sources, that Valeant reached out to Zoetis as a courtesy to common shareholder Ackman and was unlikely to pursue an acquisition of the company, though he cautioned then Valeant could change its approach and pursue a deal. BAYER: Jefferies analyst Jeffrey Holford said in a note today that he views a tie-up between Zoetis and Bayer's Animal Health business in 2016 as "highly likely." He sees Mylan's (MYL) acquisition of Abbott's (ABT) non‑U.S. developed markets specialty and branded generics business as a potential proxy for how a transaction could be structured, adding that such a "spinversion" could achieve up to 36% long-term earnings accretion for Zoetis. Holford reiterated a Buy rating on Zoetis with a $60 price target, while downgrading Bayer to Hold, citing valuation following the recent outperformance of its shares. IDEXX: While being discussed as a target, some analysts have also opined on companies that Zoetis could pursue as a buyer. On June 29, Canaccord said that in investor meetings with IDEXX (IDXX) executives declined to comment on Zoetis' potential interest in scaling up its animal health diagnostics business. Canaccord added that it thought Zoetis could make a bid for IDEXX. The firm reiterated its Buy rating and $80 price target on IDEXX shares at that time. PRICE ACTION: Since June 25, the day the Journal first reported on Valeant's preliminary takeover approach to Zoetis, the animal health company's shares have dropped nearly 4%. Zoetis closed down 20c to $47.80 on Friday.
08:28 EDTBMYExelixis off highs, but still up 34% after Bristol-Myers data
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08:25 EDTNVSNovartis management to meet with JPMorgan
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08:05 EDTBMYBristol-Myers says Phase III study evaluating Opdivo stopped early
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07:33 EDTBMY, ABTInternational AIDS Society to hold a conference
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07:32 EDTNVSAlzheimer's Association to hold a conference
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07:30 EDTABTZoetis 'highly likely' to merge with Bayer unit in 2016, says Jefferies
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