Guard Therapeutics International AB (publ) announced that the U.S. Food and Drug Administration (FDA) has granted RMC-035 (ROSgard) Fast Track designation for reducing the risk of an irreversible loss of kidney function, initiation of kidney replacement therapy or death following open-chest cardiac surgery in patients who are at increased risk for acute kidney injury. FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs aimed at treating serious conditions which have a large unmet medical need, with the goal to provide patients earlier access to such drugs. The investigational drug RMC-035 is being developed as an intravenous short-term treatment against acute kidney injuries (AKI) and is currently being evaluated in a comprehensive global Phase 2 study (AKITA) to document its renal protective effect in patients undergoing open cardiac surgery.

In addition, a Phase 1b study is underway in patients undergoing kidney transplantation.