Biotech Stocks Facing FDA Decision In November 2019

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RedHill Biopharma
RedHill Biopharma

The FDA decision on RedHill Biopharma Ltd.’s (RDHL) New Drug Application for Talicia, proposed for the treatment of H. pylori infection, is expected on November 2, 2019.

Talicia is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, Rifabutin, and Amoxicillin, and a proton pump inhibitor (PPI), Omeprazole.

In one of the phase III studies, Talicia demonstrated 89.4% efficacy in eradicating H. pylori infection while another confirmatory study demonstrated 84% eradication of H. pylori infection with Talicia compared to 58% in the active comparator group.

The current standard-of-care therapies for H. pylori infection are the triple therapies based on a proton pump inhibitor, clarithromycin, and amoxicillin or metronidazole.

According to the Company, the current standard-of-care therapies for H. pylori infection fail in approximately 30-40% of patients due to increasing antibiotic resistance.

RedHill is optimistic that Talicia has the potential to become the new first-line, standard-of-care therapy for H. pylori infection.

RDHL closed Friday’s trading (Oct.25, 2019) at $6.28, up 0.48%.