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News Breaks
January 29, 2013
18:33 EDTISIS, SNYSanofi, Isis announced FDA approval of Kynamro injection
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that the U.S. Food and Drug Administration has approved its New Drug Application for Kynamrotm injection. Kynamro, given as a 200 mg weekly subcutaneous injection, has been approved as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol, apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol in patients with homozygous familial hypercholesterolemia. Kynamro contains a Boxed Warning citing the risk of hepatic toxicity. Patients taking Kynamro should have liver enzyme testing before starting the drug and periodically thereafter. The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of Kynamro on cardiovascular morbidity and mortality has not been determined.
News For SNY;ISIS From The Last 14 Days
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May 5, 2015
10:02 EDTISISIsis Pharmaceuticals reports Q1 EPS (14c), consensus (20c)
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May 4, 2015
11:04 EDTISISIsis Pharmaceuticals partnership deal generally expected, says Piper Jaffray
Piper Jaffray noted that Isis Pharmaceuticals (ISIS) had been indicating a high level of interest in its FXIrx anti-clotting antisense program ahead of announcing its deal with Bayer (BAYRY) and the firm believes the announcement of a partnership pact was generally expected. The firm said it already included "meaningful" economics from the FXI program in its valuation for Isis and maintains a Neutral rating on the stock, which is up 4.6% to $60.92 in morning trading.
09:03 EDTISISIsis Pharmaceuticals enters into license agreement with Bayer HealthCare
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May 1, 2015
07:43 EDTSNYExpensive drugs drove over 25% of 2013 Medicare drug spending, WSJ says
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April 30, 2015
16:54 EDTISISIsis Pharmaceuticals earns $10M milestone payment from Biogen
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05:41 EDTSNYSanofi sees FY15 business EPS to be stable to slightly growing vs. 2014
The positive currency impact on 2015 full-year business EPS is estimated to be approximately 12%, under the assumption that exchange rates remain stable in the following three quarters at the average rates of March 2015.
05:40 EDTSNYSanofi reports Q1 business EPS 1.32 vs. EUR 1.17 last year
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April 28, 2015
05:30 EDTSNYGenzyme says FDA grants fast track designation for development of GZ/SAR402671
Genzyme, a Sanofi company, announced that the FDA has granted Fast Track designation for the development of GZ/SAR402671, a new investigational oral substrate reduction therapy for the treatment of Fabry disease. FDAs Fast Track Drug Development Program is designed to facilitate frequent interactions with the FDA review team to expedite the clinical development and review of a New Drug Application, or NDA, for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs for such disease or conditions. It also provides the opportunity to submit sections of an NDA on a rolling basis before a sponsor submits the complete application. Genzyme is currently enrolling patients in its Phase 2a trial of GZ/SAR402671, and plans to enroll nine treatment-nave male adult patients with Fabry disease in this international, multicenter study.
April 27, 2015
06:19 EDTSNYPharmceutical companies buy drugs and raises prices, WSJ reports
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April 24, 2015
09:32 EDTISISJPMorgan Smid biotech analysts hold an analyst/industry conference call
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April 22, 2015
16:25 EDTISISIsis Pharmaceuticals reports positive data from ISIS-TTR Rx
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10:02 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Alcatel-Lucent (ALU) upgraded on post-merger outlook at Bernstein... Amazon.com (AMZN) upgraded to Buy, price target raised to $450 at Monness Crespi... BNP Paribas (BNPQY) upgraded to Overweight from Equal Weight at Morgan Stanley... Dolby (DLB) upgraded to Overweight from Neutral at JPMorgan... First Defiance (FDEF) upgraded to Outperform from Market Perform at Raymond James... Gran Tierra (GTE) upgraded to Buy from Neutral at Dundee... Grupo Aval (AVAL) upgraded to Buy from Neutral at Goldman... Manhattan Associates (MANH) upgraded to Buy from Hold at Benchmark Co.... Marriott (MAR) upgraded to Buy from Neutral at MKM Partners... Masco (MAS) upgraded to Outperform from Market Perform at FBR Capital... Nokia (NOK) upgraded on post-merger outlook at Bernstein... Packaging Corp. (PKG) upgraded to Buy from Hold at Deutsche Bank... Rayonier (RYN) upgraded to Sector Perform from Underperform at RBC Capital... Rogers Communications (RCI) upgraded to Buy from Neutral at BofA/Merrill... Sanofi (SNY) upgraded to Neutral from Sell at Citigroup... Select Comfort (SCSS) upgraded to Outperform from Neutral at Wedbush... UniCredit (UNCFF) upgraded to Buy from Sell at Berenberg... Zions Bancorp (ZION) upgraded to Outperform from Market Perform at FBR Capital.
07:07 EDTSNYEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
06:52 EDTSNYSanofi upgraded to Neutral from Sell at Citigroup
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