India, March 18 -- RedHill Biopharma Ltd. (RDHL) announced Tuesday its plan to submit a UK Marketing Authorisation Application or MAA for Talicia for treatment of helicobacter pylori (H. pylori) infection. Utilizing the U.S. Food and Drug Administration approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025.
In pre-market activity on the Nasdaq, the specialty biopharmaceutical company's shares were losing around 10.3 percent to trade at $2.70. On Monday's regular trading, the shares had gained 17.6% to $3.01.
The MAA has been submitted under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process fo...