Denali Therapeutics Inc.
AVLAYAH™
Hunter syndrome (MPS II)
Resolved
104days ago
Approval decision · Mar 25, 2026
What's at stake
A final FDA approval decision on AVLAYAH™ for Hunter syndrome (MPS II) is expected Mar 25, 2026.
Primary source
· SEC 8-K
verified 17h ago
“Denali announced AVLAYAH (tividenofusp alfa-eknm) received accelerated approval for the treatment of neurologic manifestations of Hunter syndrome (MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least ”