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News Breaks
January 29, 2013
09:20 EDTISIS, SNYFDA PDUFA Date for Genzyme and Isis Pharmaceuticals' Kynamro
The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date for the review of Genzyme, a Sanofi company, and Isis Pharmaceuticals' Kynamro, for treatment of patients with homozygous familial hypercholesterolemia, of January 29, 2013.
News For SNY;ISIS From The Last 14 Days
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March 30, 2015
11:18 EDTSNYPDL BioPharma rises after Cerdelga approved in Japan
Genzyme, a Sanofi (SNY) company, announced earlier that the Ministry of Health, Labor and Welfare has granted marketing approval for Cerdelga as oral therapy for the treatment of adults with Gaucher disease type 1 in Japan. PDL BioPharma (PDLI) announced on November 6 that it has acquired a portion of the University of Michigan's worldwide royalty interest in Cerdelga for $65.6M. Under the terms of the royalty agreement, PDL will receive 75% of all royalty payments due under U-M's license agreement with Genzyme until expiration of the licensed patents, excluding any patent term extension. The royalty rate used to calculate the royalties to be paid by Genzyme to U-M was not disclosed by the parties. Shares of PDL BioPharma are up 12c, or 1.8%, to $7.16 in morning trading.
11:01 EDTSNYSanofi's Genzyme says Cerdelga capsules approved in Japan
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March 27, 2015
14:04 EDTSNYRegeneron price target raised to $500 from $450 at Argus
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March 26, 2015
11:13 EDTSNYBofA/Merrill European pharma analyst holds an analyst/industry conference call
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10:10 EDTISISAnalyst calls sharp pullback in biotech stocks 'misguided'
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06:45 EDTISISBiotech valuation concerns 'misguided,' says Piper Jaffray
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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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March 23, 2015
09:45 EDTSNYUBS to hold a field trip
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07:04 EDTISISIsis Pharmaceuticals says ISIS-ANGPTL3Rx 'well tolerated' in Phase 1 study
Isis Pharmaceuticals announced positive results from a Phase 1 study with ISIS-ANGPTL3Rx. In this study, healthy volunteers treated with ISIS-ANGPTL3Rx achieved dose-dependent, statistically significant reductions in angiopoietin-like 3 of up to 93% with a mean reduction of up to 84% from baseline. In addition, statistically significant reductions from baseline in lipid parameters were observed, including up to 63% with a mean reduction of up to 49% in triglycerides and up to 46% with a mean reduction of up to 28% in total cholesterol. ANGPTL3 is a protein that acts as a key regulator of these blood lipids. These data were presented at the 83rd European Atherosclerosis Society in Glasgow, United Kingdom. The Phase 1 study of ISIS-ANGPTL3Rx was a blinded, placebo-controlled, dose-escalation study in healthy volunteers. The study was designed to assess the safety, tolerability and pharmacokinetics of ISIS-ANGPTL3Rx. ISIS-ANGPTL3Rx was evaluated in single and multiple doses ranging from 50 mg per week up to 400 mg per week for the single dose and 100 mg per week up to 400 mg per week for the multiple dose. In this study, ISIS-ANGPTL3Rx was generally well tolerated.
March 20, 2015
11:45 EDTISISIsis Pharmaceuticals management to meet with Needham
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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 EDTISISOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Aimco (AIV) initiated with an Outperform at RW Baird... Alnylam (ALNY) initiated with a Buy at Janney Capital... American Campus (ACC) initiated with a Neutral at RW Baird... AvalonBay (AVB) initiated with a Neutral at RW Baird... BE Aerospace (BEAV) initiated with a Buy at CRT Capital... BlackRock (BLK) initiated with a Buy at Argus... Camden Property (CPT) initiated with an Outperform at RW Baird... CarMax (KMX) initiated with a Buy at Evercore ISI... Central Pacific (CPF) initiated with a Neutral at Macquarie... Cognex (CGNX) initiated with a Buy at Northcoast... Education Realty (EDR) initiated with a Neutral at RW Baird... EnerSys (ENS) initiated with an Overweight at Stephens... Equity Lifestyle (ELS) initiated with an Outperform at RW Baird... Equity Residential (EQR) initiated with a Neutral at RW Baird... Essex Property Trust (ESS) initiated with a Neutral at RW Baird... Facebook (FB) initiated with a Buy at Brean Capital... Intercept (ICPT) initiated with a Hold at MLV & Co.... Isis Pharmaceuticals (ISIS) initiated with a Neutral at Janney Capital... LinkedIn (LNKD) initiated with a Sell at Brean Capital... Mid-America Apartment (MAA) initiated with an Outperform at RW Baird... NetSuite (N) initiated with a Hold at Brean Capital... Paycom (PAYC) initiated with a Buy at Brean Capital... Platform Specialty Products (PAH) initiated with a Buy at UBS... Post Properties (PPS) initiated with a Neutral at RW Baird... Salesforce.com (CRM) initiated with a Hold at Brean Capital... ServiceNow (NOW) initiated with a Buy at Brean Capital... Snap-On (SNA) initiated with a Buy at Northcoast... Sun Communities (SUI) initiated with a Neutral at RW Baird... Twitter (TWTR) initiated with a Buy at Brean Capital... UDR, Inc. (UDR) initiated with an Outperform at RW Baird... Workday (WDAY) initiated with a Hold at Brean Capital... Xplore Technologies (XPLR) initiated with a Buy at Roth Capital... Yahoo (YHOO) initiated with a Hold at Argus.
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:20 EDTISISIsis Pharmaceuticals initiated with a Neutral at Janney Capital
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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

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