New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 7, 2014
13:10 EDTSNY, REGNRegeneron, Sanofi advised by FDA of adverse events in PCSK9 inhibitor class
In a filing with the SEC earlier today, Sanofi (SNY) disclosed that the company and Regeneron (REGN) have been advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. Neither company knows the circumstances under which the FDA became aware of these adverse events or whether these adverse events were observed with a drug candidate tested as monotherapy or in combination with a statin or other cholesterol-lowering agent. The FDA has requested that Sanofi and Regeneron make an assessment of potential neurocognitive adverse events across the global development program for alirocumab, especially in the longer-term studies. While neither company is aware of any neurocognitive adverse event signal relating to alirocumab, if this or another adverse event signal is detected, the further development of alirocumab may be delayed or fail, or its commercial value diminished, which could severely harm future prospects.
News For REGN;SNY From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent news | >>
March 26, 2015
11:13 EDTSNYBofA/Merrill European pharma analyst holds an analyst/industry conference call
Subscribe for More Information
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
Subscribe for More Information
11:03 EDTREGNRegeneron confirms FDA approval of EYLEA
Subscribe for More Information
10:35 EDTREGNFDA approves expanded indication for Eylea
Subscribe for More Information
March 23, 2015
09:45 EDTSNYUBS to hold a field trip
Subscribe for More Information
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
Subscribe for More Information
08:05 EDTREGNRegeneron initiated with a Buy at Chardan
Subscribe for More Information
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
Subscribe for More Information
March 18, 2015
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
Subscribe for More Information
March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
Subscribe for More Information
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 EDTSNY, REGNPCSK9 data continues to impress, says Leerink
Subscribe for More Information
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
Subscribe for More Information
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."
1 | 2 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use