Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH® (tividenofusp alfa-eknm) as Best Biotechnology Product

Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that AVLAYAH ® (tividenofusp alfa-eknm) has been recognized as the “Best Biotechnology Product” of 2026 by The Galien Foundation . AVLAYAH is the first biologic approved by the U.S. Food and Drug Administration (FDA) that is specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. AVLAYAH is an enzyme replacement therapy that received FDA accelerated approval in March 2026 for the treatment of neurologic manifestations of a rare neurodegenerative disease called Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory study.