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Denali shares were up 4.2% at $21.86.
The FDA has approved Denali Therapeutics' Avlayah for treating Hunter syndrome.
KEY POINTS
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.