RedHill Biopharma Ltd. (RDHL) Announces FDA Acceptance of IND Application for RHB-105 (H. pylori) Phase 3 Study - to Commence Shortly
10/22/2013 9:53:51 AM
TEL-AVIV, Israel, Oct. 22, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for the ERADICATE Hp study - a Phase III clinical study with RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection. The Company plans to commence the Phase III study in the U.S. by the end of this month, subject to final preparations.
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