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FDA Approves Denali's Avlayah for Pediatric Hunter Syndrome

3/26/2026

26 3 Full Breakdown

Summary

Story summary

On March 25, 2026, the U.S. Food and Drug Administration approved Denali Therapeutics' Avlayah for Hunter syndrome in pediatric patients.
This marks Denali Therapeutics' first U.S. regulatory approval.
The decision relied on a surrogate endpoint indicating potential clinical benefit.
The approval is contingent on a confirmatory trial.
Avlayah is administered weekly and carries a boxed warning for severe allergic reactions, priced at $5,200 per vial.

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Story summary

On March 25, 2026, the U.S. Food and Drug Administration approved Denali Therapeutics' Avlayah for Hunter syndrome in pediatric patients.
This marks Denali Therapeutics' first U.S. regulatory approval.
The decision relied on a surrogate endpoint indicating potential clinical benefit.
The approval is contingent on a confirmatory trial.
Avlayah is administered weekly and carries a boxed warning for severe allergic reactions, priced at $5,200 per vial.