04:23 AM EDT, 07/01/2025 (MT Newswires) -- Mesoblast (MESO) said late Monday it has aligned with the US Food and Drug Administration on the items required for filing a biologics license application for Revascor to treat ischemic heart failure with reduced ejection fraction and inflammation.

The alignment came as a follow-up to the successful early 2024 meeting under the Revascor's regenerative medicine advanced therapy designation in which the FDA stated that the study results could support accelerated approval, the company said.

Mesoblast said it met with the FDA June 3 to align on chemistry, manufacturing and controls, potency assays for commercial product release, and design and primary endpoint for the trials for a filing, the company said.

The company said it plans to file the application for accelerated approval by the end of the year.