Coya Therapeutics, Inc. (NASDAQ:COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for COYA 302, a proprietary investigational biologic combination therapy with a dual mechanism of action, for the treatment of amyotrophic lateral sclerosis (ALS).

The FDA Fast Track Designation is a program designed to facilitate and expedite the development and review of drugs and biologics intended to treat serious or life-threatening conditions. Its primary purpose is to ensure that promising new therapies reach patients as quickly as possible through several key regulatory advantages, which include more frequent FDA interactions, potential for rolling review, and eligibility for expedited programs such as Accelerated Approval and Priority Review.