Denali Therapeutics Inc.

Approval Confirmed

AVLAYAH (tividenofusp alfa-eknm)

Hunter Syndrome (MPS II)

Resolved

104days ago

Approval decision · Mar 25, 2026

What's at stake A final FDA approval decision on AVLAYAH (tividenofusp alfa-eknm) for Hunter Syndrome (MPS II) is expected Mar 25, 2026.

Primary source · SEC 8-K verified 15h ago

“Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II) March 25, 2026”