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News Breaks
August 25, 2014
07:55 EDTREGN, REGN, SNY, SNYSanofi and Regeneron co-host a conference call
In conjunction with the European Society of Cardiology Conference, Sanofi and Regeneron discuss Alirocumab (SAR236553/ REGN727) on a conference call to be held on September 2 at 8:30 am. Webcast Link
News For REGN;SNY From The Last 14 Days
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March 26, 2015
05:29 EDTSNYGenzyme reports Cerdelga data shows effectiveness in treating Gaucher disease
Genzyme, a Sanofi company, announced the publication of results from the ENCORE study exploring Cerdelga as a maintenance therapy suitable for adult patients who had reached pre-specific treatment goals on enzyme replacement therapy, or ERT, in the March 26 online issue of The Lancet. ENCORE is a randomized, multinational, Phase 3, open-label, non-inferiority study designed to determine whether patients with Gaucher disease type 1 who had been stabilized after 3 or more years of ERT infusions would remain stable after switching to Cerdelga, a novel, oral, selective inhibitor of glucosylceramide synthase. Eligible patients were randomized 2:1 to receive either oral Cerdelga or ERT with Cerezyme over a period of 12 months. The composite primary efficacy endpoint was the percentage of patients whose hematologic parameters and organ volumes remained stable, using the following stability criteria established for patients with Gaucher disease type 1 on maintenance therapy with Cerezyme: Hemoglobin concentration that did not decrease more than 1.5 g/dL; Platelet count that did not decrease more than 25%; Spleen volume that did not increase more than 25%; Liver volume that did not increase more than 20%. After 12 months, 85% of patients receiving Cerdelga and 94% of patients receiving Cerezyme met the composite endpoint of stability in all four of these measures. The difference between the two treatments was within the pre-specified margins. The principal secondary endpoints were stability with respect to the individual components of the primary endpoint. At least 93% of Cerdelga patients remained stable with respect to hemoglobin concentration, platelet count, spleen volume, and liver volume after 12 months of treatment. Additional endpoints evaluated bone disease, Gaucher disease severity, quality-of-life and Gaucher-disease associated biomarkers.
March 25, 2015
12:17 EDTSNYSanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine
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11:03 EDTREGNRegeneron confirms FDA approval of EYLEA
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10:35 EDTREGNFDA approves expanded indication for Eylea
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March 23, 2015
09:45 EDTSNYUBS to hold a field trip
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07:17 EDTREGNAmerican Academy of Dermatology to hold annual meeting
73rd Annual Meeting of AAD is being held in San Francisco on March 20-24.
March 20, 2015
10:00 EDTREGNOn The Fly: Analyst Initiation Summary
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08:05 EDTREGNRegeneron initiated with a Buy at Chardan
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March 19, 2015
07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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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
08:23 EDTREGN, SNYPCSK9 data continues to impress, says Leerink
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07:16 EDTSNY, REGNRegeneron 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 EDTSNY, REGNPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
13:04 EDTSNY, REGNSanofi, 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."
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