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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-520’s 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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November 19, 2014
07:52 EDTALNYInforma Business Information to hold a conference
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November 18, 2014
07:32 EDTARWRArrowhead files for regulatory permission to begin Phase I ARC-AAT trial
Arrowhead Research recently filed an application for approval to begin a Phase 1 clinical trial of its RNAi-based therapeutic candidate, ARC-AAT, for the treatment of liver disease associated with alpha-1 antitrypsin deficiency. Pending approval, Arrowhead intends to proceed with a double blind, placebo-controlled dose escalation, Phase 1 study to determine the safety, tolerability, pharmacokinetics and effect on circulating alpha-1 antitrypsin levels of ARC-AAT in healthy volunteers and patients with alpha-1 antitrypsin deficiency. The study is planned to start in Australia in healthy volunteers and will dose escalate until predetermined levels of alpha-1 antitrypsin reduction are reached. Once these levels of protein knockdown are achieved, the study will transition into a population of patients with ZZ genotype alpha-1 antitrypsin deficiency to further evaluate escalating doses of ARC-AAT. The study is designed to enroll up to 48 subjects, including healthy volunteers and alpha-1 antitrypsin deficiency patients. The application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.
November 17, 2014
17:03 EDTALNYAlnylam presents new pre-clinical data on RNAi therapeutic programs
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07:09 EDTALNYAmerican Heart Association to hold a conference
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November 14, 2014
06:31 EDTALNYAlnylam to host conference call
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06:04 EDTALNYAlnylam announces positive initial phase 2 data with Revusiran
Alnylam announced positive initial Phase 2 data with revusiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR cardiac amyloidosis. In the pilot Phase 2 study, revusiran was found to be generally well tolerated in TTR cardiac amyloidosis patients. Revusiran demonstrated clinical activity with an up to 98.2% knockdown of serum TTR – the disease causing protein. This included similar knockdown effects toward wild type and mutant TTR protein within V122I patients, who represent the most common genotype associated with inherited forms of TTR cardiac amyloidosis. In the five week course of treatment, there were no significant changes observed in a number of exploratory clinical measurements. Revusiran utilizes Alnylam’s proprietary GalNAc-conjugate delivery platform that enables subcutaneous delivery of RNAi therapeutics with a wide therapeutic index. The primary objective of the study was to evaluate the safety and tolerability of revusiran. The secondary objectives were to assess the clinical activity of revusiran toward serum levels of TTR and characterize the drug’s pharmacokinetic profile. In addition, a number of exploratory clinical measurements were performed at baseline and days 42 and 90 after start of dosing.
November 11, 2014
08:03 EDTALNYAlnylam adds ALN-HDV, ALN-PDL to hepatic infectious disease pipeline
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November 10, 2014
09:18 EDTARWRArrowhead announces presentation of ongoing Phase 2a ARC-520 data
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November 9, 2014
14:09 EDTALNYAlnylam management to meet with Needham
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