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June 13, 2014
17:50 EDTALNY, ARWRArrowhead Research reiterates patent position
Arrowhead Research (ARWR) reaffirmed its belief that it has broad access to intellectual property required to develop ARC-520, its clinical candidate against chronic hepatitis B infection. Arrowhead does not believe there are additional unlicensed patents directed to RNAi therapeutics targeting the hepatitis B virus that affect its freedom to operate. The company signed a license agreement with Alnylam Pharmaceuticals (ALNY) in January 2012, giving it access to intellectual property that enables the discovery, development, and commercialization of an RNAi therapeutic targeting the hepatitis B virus. Arrowhead holds multiple levels of patent protection on ARC-520 including U.S. Patent Nos. 8,313,772 and 8,501,930 covering the Dynamic Polyconjugate delivery system, and U.S. Patent Application number 13/535,454 covering ARC-520ís siRNA component, which was recently allowed by the U.S. Patent and Trademark Office. Arrowhead and its legal advisors continually review the patent landscape to ensure freedom to operate and the company believes that development and commercialization of ARC-520 would not infringe patents governing RNAi therapeutics targeting the hepatitis B virus, including U.S. Patent No. 8,618,277 in the McSwiggen patent estate.
News For ARWR;ALNY From The Last 14 Days
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December 19, 2014
08:01 EDTALNYAlnylam announces planned departure of Chief Business Officer
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December 18, 2014
08:09 EDTALNYAlnylam names Cubist CEO Michael Bonney to board of directors
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December 15, 2014
08:42 EDTALNYAlnylam price target raised to $125 from $105 at Leerink
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07:33 EDTARWRArrowhead submits IND for ARC-520 to begin Phase 2b studies
Arrowhead Research announced that it submitted an Investigational New Drug application to the U.S. Food and Drug Administration for ARC-520, itís drug candidate for the treatment of chronic hepatitis B virus infection. Arrowhead plans to submit additional clinical trial authorization applications with regulatory authorities in various jurisdictions in Europe and Asia. Pending national regulatory review and approval, Arrowhead intends to initiate two Phase 2b, multicenter, randomized, double-blind, placebo-controlled, multi-dose studies to determine the depth of hepatitis B surface antigen reduction following ARC-520 injection in combination with entecavir or tenofovir in patients with chronic immune active HBV infection. The Heparc-2002 study is planned to include patients who are negative for hepatitis B e-antigen at screening and the Heparc-2003 study is planned to include patients who are positive for HBeAg at screening. The primary objective is to evaluate the depth of HBsAg decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic HBV infection as a measure of drug activity. Secondary objectives are to assess measures of safety and tolerability and to evaluate multi-dose pharmacokinetics of ARC-520 in patients with chronic HBV infection when co-administered with a fixed dose of entecavir or tenofovir, in addition to other exploratory safety and pharmacodynamic objectives.
06:06 EDTALNYAlnylam price target raised to $158 from $134 at Piper Jaffray
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December 12, 2014
10:01 EDTALNYOn The Fly: Analyst Initiation Summary
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07:05 EDTALNYAlnylam sees filing IND for ALN-HBV DC program in late 2015
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07:03 EDTALNYAlnylam sees initial data from ALN-PCSsc trial in mid-2015
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07:02 EDTALNYAlnylam updates guidance to file clinical trial application for ALN-AS1
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05:30 EDTALNYAlnylam initiated with a Neutral at Goldman
Goldman started shares of Alnylam Pharmaceuticals with a Neutral rating and $113 price target saying it prefers to wait for a more favorable entry point into the name.
December 11, 2014
16:02 EDTALNYAlnylam initiates ENDEAVOUR Phase 3 clinical trial with revusiran
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13:09 EDTARWRArrowhead mentioned positively by Agora Financial
Agora Financial believes investors can "double [their] money ó virtually overnight." and have a "realistic chance" to make "up to 10 times [their] money" by investing in Arrowhead Research, according to a new research report from the firm. Arrowhead shares are up nearly 10% to $5.98 in afternoon trading. Reference Link
08:02 EDTALNYAlnylam, The Medicines Co. announce initiation of Phase 1 ALN-PCSsc trial
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December 9, 2014
12:22 EDTALNYPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
06:38 EDTALNYAlnylam to host conference call
Conference call to discuss Phase 1 data from ALN-AT3, in development for the treatment of hemophilia will be held on December 9 at 8 am. Webcast Link
05:47 EDTALNYAlnylam reports poisitve initial results for ALN-AT3
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