# FDA Approves AVLAYAH for Hunter Syndrome, First Drug to Cross Blood-Brain Barrier via Transferrin Receptor

> fda · REPORTED · 2026-05-07

The FDA approved AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome (MPS II), establishing it as the first medicine to leverage the transferrin receptor to cross the blood-brain barrier and reach the CNS. Denali reported first patients were treated in a commercial setting in April 2026 following the approval.

- Company: Denali Therapeutics
- Sector: biotech
- Primary source: https://www.sec.gov/Archives/edgar/data/0001714899/000171489926000062/ex991pressreleaseq12026.htm

---
Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.