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RedHill Bio's Talicia nabs accelerated review status for H. pylori infection

|About: RedHill Biopharma Ltd. (RDHL)|By:, SA News Editor

The FDA has accepted for review RedHill Biopharma's (NASDAQ:RDHL) NDA for Talicia (RHB-105) for H. pylori infection. The NDA has also been granted Priority Review designation.

PDUFA action date is November 2, 2019.

If approved, Talicia would be eligible for eight years of U.S. market exclusivity.

Talicia (RHB-105) is an oral capsule combination of two antibiotics, rifabutin, and amoxicillin, and a proton pump inhibitor, omeprazole.

Shares are up 3% premarket.

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