Akava Therapeutics, Inc. announces that on July 6, 2022, orphan drug designation (ODD) status was received for AKV9 for the treatment of amyotrophic lateral sclerosis (ALS) from the U.S. Food and Drug Administration (FDA), pursuant to section 526 of the Federal, Drug and Cosmetic Act (12 U.S.C.360bb). Obtaining orphan drug designation represents a significant company milestone. Akava is presently in IND enabling studies and plans to have a pre-IND meeting with the FDA later this year prior to filing the IND.