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Stock Market & Financial Investment News

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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February 27, 2015
09:43 EDTISISIsis Pharmaceuticals sees reporting data on eight or more drugs in FY15
Sees initiating up to 13 studies, broadening pipeline with up to five new drugs in partnered, unpartnered programs.
09:38 EDTISISIsis Pharmaceuticals sees FY15 pro forma NOL in mid-$50M range
Sees ending FY15 with more than $630M in cash, representing net cash outflows of only $100M to move forward its pipeline.
09:34 EDTISISIsis Pharmaceuticals reports Q4 EPS 25c, consensus 2c
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07:22 EDTSNYSanofi reports positive opinion from CHMP for Toujeo
Sanofi announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion recommending the approval of Toujeo, a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus with low within-individual, within-day blood sugar variability. The European Commission is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the FDA and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units, and it has a maximum single injection dose of 80 IU.
February 26, 2015
15:30 EDTISISNotable companies reporting before tomorrow's open
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05:32 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
Sanofi announced that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations.
February 25, 2015
20:05 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
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February 24, 2015
10:48 EDTISISIsis says ISIS-PKKRx reduced prekallikrein levels in Phase 1 study
Isis Pharmaceuticals announced results from a Phase 1 study with ISIS-PKKRx. In this study, healthy volunteers treated with ISIS-PKKRx achieved dose-dependent reductions of up to 95% in prekallikrein, or PKK, Isis said. ISIS-PKKRx is a RNA-targeted antisense drug designed to inhibit the production of PKK for the prophylactic treatment of hereditary angioedema. ISIS-PKKRx 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 up to 400 mg for the multiple doses. After three weeks of dosing, subjects in the 100, 200, 300 and 400 mg multiple-dose cohorts displayed a mean reduction of PKK of 33, 69, 87 and 92%, respectively, from baseline. In this study, ISIS-PKKRx was generally well tolerated.
February 23, 2015
07:22 EDTISISSunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.
February 20, 2015
15:20 EDTISISIsis Pharmaceuticals management to meet with JPMorgan
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07:08 EDTSNYAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
16:50 EDTSNYSanofi appoints Olivier Brandicourt CEO
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09:59 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Altisource Residential (RESI) upgraded to Neutral from Sell at Compass Point... Angie's List (ANGI) upgraded to Overweight from Equal-Weight at First Analysis... Barrick Gold (ABX) upgraded to Buy from Hold at TD Securities... British Land (BTLCY) upgraded to Buy from Hold at Societe Generale... Coach (COH) upgraded to Buy from Hold at Topeka... Fiat Chrysler (FCAU) upgraded to Outperform from Neutral at Exane BNP Paribas... Garmin (GRMN) upgraded at BofA/Merrill... Hologic (HOLX) upgraded to Buy from Hold at Canaccord... Iberdrola (IBDRY) upgraded to Neutral from Underweight at HSBC... KPN (KKPNY) upgraded to Neutral from Underperform at Exane BNP Paribas... Monster Worldwide (MWW) upgraded at Evercore ISI... Pharmacyclics (PCYC) upgraded to Buy from Neutral at Nomura... RPC, Inc. (RES) upgraded to Equal Weight from Underweight at Morgan Stanley... Sanofi (SNY) upgraded to Buy from Neutral at BofA/Merrill... Sasol (SSL) upgraded to Neutral from Underweight at HSBC... Tractor Supply (TSCO) upgraded at Oppenheimer... Valero (VLO) upgraded to Buy from Hold at Deutsche Bank... Weingarten Realty (WRI) upgraded to Neutral from Sell at UBS... Werner (WERN) upgraded on improving freight fundamentals at RBC Capital... diaDexus (DDXS) upgraded to Buy from Neutral at Ladenburg,
06:21 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
05:31 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
February 17, 2015
11:38 EDTSNYGenzyme reports publication of ENGAGE registration study results
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