# How Denali passed the FDA's new biomarker test for rare disease drugs

- slug: how-denali-passed-the-fdas-new-biomarker-test-for-rare-disease-drugs
- date: 2026-03-25
- category: Biotech & Life Sciences

The Food and Drug Administration on Wednesday approved a new therapy from Denali Therapeutics for Hunter syndrome, clearing a drug that can do something no existing treatment for the disease has ever managed: reach the brain.

Avlayah (tividenofusp alfa-eknm) is an enzyme replacement therapy desi...

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