Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH® (tividenofusp alfa-eknm) as Best Biotechnology Product
Key Highlights
- ➤AVLAYAH wins 2026 Prix Galien USA Best Biotechnology Product award
- ➤AVLAYAH received FDA accelerated approval in March 2026 for pediatric Hunter syndrome
- ➤AVLAYAH is the first FDA-approved biologic specifically designed to cross the blood-brain barrier
- ➤Continued approval may depend on confirmatory verification of clinical benefit
- ➤Denali is advancing TransportVehicle-enabled candidates for Sanfilippo syndrome and Alzheimer’s disease
Expert Statements
Ryan Watts, Co-founder and Chief Executive Officer of Denali Therapeutics
“We are honored to receive the Best Biotechnology Product Award for AVLAYAH, which is a culmination of years of pioneering research to solve the challenge of delivering biologics across the blood-brain barrier with our TransportVehicle technology”
Ryan Watts, Co-founder and Chief Executive Officer of Denali Therapeutics
“This recognition also belongs to the Hunter syndrome community and the families, advocates and clinicians whose determination and commitment made AVLAYAH possible.”
Ryan Watts, Co-founder and Chief Executive Officer of Denali Therapeutics
“An FDA-approved medicine that reaches the brain offers transformative possibilities for this community, and it is proof that we can bring the power of biologic medicines to the brain for rare genetic diseases and common neurodegenerative disorders that affect millions of people worldwide.”
* First FDA-approved biologic specifically designed to cross blood-brain barrier wins award dedicated to exceptional scientific leadership and transformational impact on patient care * First new FDA-approved treatment option in nearly 20 years for families living with Hunter syndrome, a rare neurodegenerative disorder * Denali’s brain delivery technology establishes foundation for potential therapies across wide range of diseases that impact the brain, including Alzheimer’s disease SOUTH SAN FRANCISCO, Calif., Oct. 30, 2026 (GLOBE NEWSWIRE) -- 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.
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