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Denali wins FDA accelerated approval for Hunter syndrome brain-penetrant enzyme therapy AVLAYAH

PUBT·07/09/2026 20:05:38
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Denali wins FDA accelerated approval for Hunter syndrome brain-penetrant enzyme therapy AVLAYAH
  • Denali Therapeutics flagged TransportVehicle-enabled Alzheimer’s candidates DNL628 (tau) and DNL921 (amyloid beta) as it targets 2027 proof-of-concept readouts.
  • DNL628 Phase 1b dosing began in H1 2026; safety and biomarker data are expected in 2027.
  • DNL921 CTA was filed in H1 2026; Phase 1/1b start depends on clearance, with 2027 safety and biomarker data targeted.
  • Denali plans to highlight its blood-brain barrier delivery strategy at AAIC 2026 in London on July 12, 2026.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Denali Therapeutics Inc. published the original content used to generate this news brief on July 09, 2026, and is solely responsible for the information contained therein.