RedHill Biopharma Ltd (RDHL)

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Redhill Biopharma Says it Evaluated Final Patient in Confirmatory Phase III Study With Talicia for H. Pylori Infection
MT NEWSWIRES 9:36 AM ET 10/24/2018

10:36 AM EDT, 10/24/2018 (MT Newswires) -- Redhill Biopharma(RDHL) said Wednesday the final patient was evaluated for primary endpoint in the confirmatory phase III study with Talicia for H. pylori infection.

The biopharmaceutical firm said that it expects to announce top-line results from the Eradicate Hp2 study before year-end. It compares Talicia against a dual therapy amoxicillin and omeprazole regimen at equivalent doses.

Subject to a successful outcome and additional regulatory feedback, it plans to file a New Drug Application with the US Food and Drug Administration early next year, with an expected six-months priority review period.

The agency had granted Qualified Infectious Disease Product designation and Fast-Track development designation to Talicia, including a total of eight years of US market exclusivity, the company added.

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