Denali initiates rolling BLA submission for tividenofusp alfa (Hunter syndrome); launch targeted late 2025/early 2026

Denali Therapeutics Inc.

Rolling BLA for accelerated approval of tividenofusp alfa (MPS II) initiated; FDA aligned on CSF HS as surrogate endpoint.
BLA submission expected to complete in first half of May 2025.
Potential U.S. commercial launch in late 2025 or early 2026.
FDA collaboration under START program for accelerated development path of DNL126 (Sanfilippo syndrome).
Productive engagement with CDER on full approval conversion path for tividenofusp alfa.

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