Denali Therapeutics

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First drug engineered to cross the blood-brain barrier wins FDA approval

Received first FDA approval; advancing broad pipeline of BBB-crossing drugs

For decades, the blood-brain barrier has blocked nearly all large-molecule drugs from reaching the brain — a biological wall that left most neurological diseases effectively untreatable with modern biologics. On March 25, 2026, the FDA approved Denali Therapeutics' AVLAYAH. It's the first drug specifically engineered to cross the blood-brain barrier and deliver a therapeutic enzyme to the central nervous system after a simple intravenous infusion.

Updated May 30