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Stock Market & Financial Investment News

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November 8, 2012
04:55 EDTDXCM, DXCM, DXCM, SNY, SNY, SNY, MDT, MDT, MDT, RHHBY, RHHBY, RHHBY, BAYRY, BAYRY, BAYRYDiabetes Technology Society to host a meeting
12th Annual Diabetes Technology Society Meeting is being held in Bethesda, Maryland on November 8-10.
News For DXCM;SNY;MDT;RHHBY;BAYRY From The Last 14 Days
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March 18, 2015
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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07:46 EDTRHHBYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
05:39 EDTMDTSt. Jude Medical downgraded to Market Perform from Outperform at Wells Fargo
Wells Fargo downgraded St. Jude Medical (STJ) to Market Perform saying competitive pressures will drive 2015 market share losses in the company's cardiac rhythm management business, which represents 50% of total sales. Wells believes the launch of CardioMEMS will not be strong enough to offset the headwinds in CRM unit. The firm thinks Boston Scientific's (BSX) earlier than expected approval for its next generation subcutaneous implantable cardioverter-defibrillator called Emblem will drive share gains against St. Jude and Medtronic (MDT) in the single chamber ICD market. Wells cut its price target range for St. Jude shares to $69-$70 from $73-$74. The medical technology company closed yesterday down $2.01 to $65.45.
March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
March 16, 2015
13:16 EDTMDTAnalysts upbeat on results of Edwards' Sapien 3 data
The shares of Edwards Lifesciences (EW) are rising after the company released data on its Sapien 3 transcathter aortic valve over the weekend. In notes to investors today, a number of analysts were upbeat on the data. BACKGROUND: Edwards yesterday announced that high- and intermediate-risk patients treated with Sapien 3 demonstrated lower mortality rates than patients treated with previous transcathter aortic valves, or TAVR, made by the company. The patients also had excellent clinical outcomes in the other primary endpoints of stroke and paravalvular regurgitation, the company stated. Meanwhile, a five year study of patients treated with the first generation SAPIEN device showed that the patients had equivalent outcomes to traditional open-heart surgery, and no structural valve deterioration requiring intervention, the company stated. ANALYST REACTION: Edwards' Sapien 3 data was impressive, as the device showed one of the lowest stroke and mortality rates of any major TAVR study so far, Bernstein analyst Derrick Sung wrote in a note to investors earlier today. Data presented by Edwards and other companies at the American College of Cardiology, or ACC, conference this weekend caused investors and the medical community to become more optimistic about the potential for TAVR devices to replace surgical valves, Sung stated. The analyst wrote that he continues to believe that investors are underestimating the potential size of the TAVR market. Also upbeat on Edwards' data was Wells Fargo, which wrote that the data exceeded high expectations and could pressure the FDA to approve Sapien 3 for intermediate risk patients earlier than Edwards' guidance of late 2016. WHAT'S NOTABLE: Analysts were also upbeat on data reported by other companies at the ACC conference. Medtronic's (MDT) data suggested that its CoreValve Evolut-R product may be as effective as Edwards' Sapien 3, Bernstein's Sung stated. The FDA appears to have allowed Boston Scientific's (BSX) left atrial appendage closure, Watchman, to be provided to more patients than expected, research firm Stifel believes. Meanwhile, St. Jude's (STJ) CardioMEMS device yielded "impressive" mortality data, the firm added. Stifel kept Buy ratings on both Medtronic and St. Jude. PRICE ACTION: In early afternoon trading, Edwards Lifesciences climbed 9% to $147.64, Boston Scientific advanced 4% to $17.27, St. Jude added 2% to $67.55, and Medtronic rose 1.3% to $77.50.
08:23 EDTSNYPCSK9 data continues to impress, says Leerink
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07:30 EDTMDTAmerican College of Cardiology to hold an expo
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07:22 EDTMDTMedtronic Edwards Lifesciences data 'impressive,' says Bernstein
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07:16 EDTSNYRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTSNYPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
15:27 EDTMDTMedtronic unveils data from high risk study of the CoreValve U.S. pivotal trial
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15:23 EDTMDTMedtronic unveils preclinical outcomes of its novel Drug-Filled Stent
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15:20 EDTMDTMedtronic announces outcomes for its next-generation CoreValve Evolut R System
Medtronic announced initial clinical outcomes for its next-generation CoreValve Evolut R System. At 30-days, the new recapturable, self-expanding valve showed no incidents of all-cause mortality or stroke in a high and extreme risk patient population. Data from the Evolut R Study, which enrolled 60 patients from six centers in the United Kingdom, Australia and New Zealand, were unveiled today at the 64th Annual Scientific Session of the American College of Cardiology. The CoreValve Evolut R System is not approved for commercial use in the United States where it is currently undergoing clinical trials. "Initial clinical experience with the Evolut R system is remarkable and ushers in a new era of TAVR technology that provides increased confidence with recapturability, excellent procedural results, and impressive clinical outcomes," said Ian Meredith, M.D., of Monash Heart - Monash Health, Melbourne, Australia, who is one of the investigators of the study. "The 14 French equivalent delivery system allowed transfemoral access for most patients and the recapturable technology enabled implanters to optimize valve placement for improved annular sealing and reduced conduction disturbances without compromise on mortality or stroke."
13:04 EDTSNYSanofi, Regeneron announce publication of results of ODYSSEY long term trial
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) today announced that 18-month results of a Phase 3 trial of Praluent, alirocumab, an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol by an additional 62% at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks."These results demonstrated the durable efficacy for Praluent when added to maximally-tolerated statin therapy and further reinforce its generally consistent safety profile," said Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent -- we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events."
March 13, 2015
10:37 EDTSNYSanofi says NHS England de-lists cabazitaxel, aflibercept
Sanofi announcd that NHS England has confirmed that it is de-listing both cabazitaxel and aflibercept from the Cancer Drugs Fund, so that neither of these medicines will be available to new patients in England on the NHS. It added, "However regarding cabazitaxel NHS England have agreed to engage in talks to explore immediate ways of maintaining access to patients until it is reviewed by NICE." Tarja Stenvall, General Manager for Sanofi in the UK, commented, "We are hugely disappointed that cabazitaxel and aflibercept have been cut from the CDF and that new patients in England will no longer have access to these crucial cancer treatments. However NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review. Our concern is for patients who should continue to have access to cabazitaxel until a longer term solution is reached and who may feel confused and uncertain until this happens."
07:09 EDTDXCMWedbush to hold field trip
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