RedHill to file FDA-approved Talicia for UK marketing

Israeli-headquartered RedHill Biopharma (Nasdaq: RDHL) today revealed its plan to submit a UK marketing authorization application (MAA) for Talicia (low-dose rifabutin-triple therapy) for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval.

Utilizing the US Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025, said RedHill, whose shares fell more than 13% to $2.61 following the announcement.