India, Oct. 30 -- Denali Therapeutics Inc. (DNLI) announced that AVLAYAH (tividenofusp alfa-eknm) has been named the 2026 Prix Galien USA Best Biotechnology Product by The Galien Foundation, recognizing its innovation in treating rare neurological diseases.
AVLAYAH is the first FDA-approved biologic specifically designed to cross the blood-brain barrier and deliver treatment to both the brain and peripheral tissues.
The U.S. Food and Drug Administration (FDA) granted accelerated approval to AVLAYAH in March 2026 for the treatment of neurologic manifestations of Hunter syndrome, also known as mucopolysaccharidosis type II (MPS II), in presymptomatic or symptomatic pediatric patients weighing at least 5 kg who have not developed advanced ne...