The U.S. Food and Drug Administration granted the application priority review status, accelerating the timeline for a potential market entry. The agency has set a target action date for November, which could provide a new therapeutic option for those grappling with the debilitating symptoms of the disease.

Across the Atlantic, the European Medicines Agency is conducting its own review of the data. The Tarrytown-based biotechnology firm anticipates a final decision from the European Commission during the second half of 2027. The drug originates from a licensing agreement between Regeneron and Alnylam, aiming to address the specific needs of patients with the anti-acetylcholine receptor antibody-positive form of the illness.