Cyclerion Therapeutics receives U.S. FDA orphan drug designation for zagociguat

Cyclerion Therapeutics announced that the U.S. Food and Drug Administration has granted orphan drug designation to zagociguat for the treatment of mitochondrial diseases. "Orphan drug designation underscores the FDA’s recognition of zagociguat’s potential promise as a first-ever therapy for patients with MELAS, a rare, genetic mitochondrial disease," said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. "Cyclerion is working expeditiously to advance this potential treatment to help address the immense unmet needs of patients with MELAS, a patient population in desperate need of therapies."