Denali's AVLAYAH Wins 2026 Prix Galien USA Best Biotechnology Product; DNLI Falls 2.35%

Denali Therapeutics Inc. (DNLI) said its AVLAYAH (tividenofusp alfa-eknm) was named the 2026 Prix Galien USA Best Biotechnology Product by The Galien Foundation, recognizing the therapy for rare neurological diseases. Denali shares were trading at $18.86, down 2.35%. AVLAYAH is the first FDA-approved biologic designed to cross the blood-brain barrier and deliver treatment to both the brain and peripheral tissues. The FDA granted accelerated approval in March 2026 for neurologic manifestations of Hunter syndrome, or mucopolysaccharidosis type II (MPS II), in presymptomatic or symptomatic pediatric patients weighing at least 5 kg without advanced neurologic impairment. The enzyme replacement therapy combines the IDS enzyme with Denali's TransportVehicle technology, which uses transferrin receptor-mediated transport. It is the first new FDA-approved treatment option in nearly 20 years for Hunter syndrome families; continued approval may depend on confirmatory study results. Denali is advancing zafinofusp alfa for Sanfilippo syndrome type A, plus Alzheimer's candidates DNL628 and DNL921. The award was presented at the American Museum of Natural History in New York.