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Stock Market & Financial Investment News

News Breaks
February 21, 2014
07:31 EDTARWRArrowhead listing upgraded to NASDAQ Global Select Market
Arrowhead Research announced that it received notice that the NASDAQ Listing Qualifications Department has approved an application to upgrade the listing of the company’s securities from the NASDAQ Capital Market to the NASDAQ Global Select Market, effective with the opening of business on February 21. The company’s stock will continue to trade under the ticker symbol “ARWR” after the upgrade.
News For ARWR From The Last 14 Days
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June 17, 2015
07:36 EDTARWRArrowhead receives regulatory clearance for additional Phase 2b ARC-520 studies
Arrowhead Research announced that its Clinical Trial Application for ARC-520, its clinical candidate for chronic hepatitis B infection, has been approved by Germany’s Federal Institute for Drugs and Medical Devices. The company now has regulatory clearance in Germany for two additional Phase 2b multiple-dose studies of ARC-520 to be conducted in parallel. Arrowhead awaits final IRB approval from the sites, which are expected shortly, and in addition, the company is engaged with regulatory authorities from Hong Kong and South Korea to open additional sites for these studies. Arrowhead will provide guidance in the future on timing for release of data from these studies. The studies titled Heparc-2002 and Heparc-2003 will enroll patients with chronic HBV infection that are e-antigen negative and HBeAg positive, respectively. Each study is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study intended to evaluate two dose levels in parallel of ARC-520 in combination with entecavir or tenofovir in patients with immune active chronic HBV infection. The 2002 and 2003 studies are planned to enroll up to 60 and 90 patients, respectively. In each study, patients will be randomized to receive four doses, once every 4 weeks, of either 1 mg/kg ARC-520, 2 mg/kg ARC-520, or placebo at a ratio of 1:1:1. For each patient, the duration of the study is approximately 33 weeks, from screening to the Day 169 follow-up visit. For each study, a planning interim analysis will be performed when 54 patients have completed their Day 71 visit. This analysis will be used to plan future studies only and will not impact the enrollment or conduct of Heparc-2002 and -2003. Based on the interim results, the company will decide whether higher multiple-doses would be likely to lead to increased activity, in which case higher doses may be evaluated in one or more additional studies. The primary objective of the 2002 and 2003 studies is to evaluate the depth of hepatitis B surface antigen decline in response to multiple doses of ARC-520 compared to placebo as a measure of drug activity. Secondary objectives include the assessment of safety and tolerability and multi-dose pharmacokinetics of ARC-520 when co-administered with entecavir or tenofovir, in addition to other exploratory objectives.

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