# Denali shares were up 4.2% at $21.86.

*biotech · news · 2026-03-25 · Newsmax*

## Key points

- The FDA has approved Denali Therapeutics' Avlayah for treating Hunter syndrome.
- This is Denali Therapeutics' first drug approval in the U.S. market.
- Avlayah is an enzyme replacement therapy targeting iduronate-2-sulfatase deficiency.
- Denali's shares rose 4.2% following the FDA approval announcement.

The Food and Drug Administration has approved Denali Therapeutics' treatment for a rare genetic disorder, the regulator said on Wednesday. The approval marks the first regulatory green light for the drugmaker in the U.S. Denali shares were up 4.2% at $21.86. Marketed as Avlayah, the enzyme replacement therapy is aimed at treating Hunter syndrome, a rare genetic disorder that leads to the buildup of certain sugar molecules in the brain and body. The disorder is caused by a deficiency of the enzyme iduronate-2-sulfatase, which prevents the body from breaking down large sugar molecules called glycosaminoglycans.

**Countries:** United States

[Read the full story on Newsmax](https://www.newsmax.com/politics/fda-denali-therapeutics-genetic-disorders/2026/03/25/id/1250750/)

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