FDA Approves Denali's Genetic Disorder Therapy

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.