---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000077"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-04-02T23:59:59+00:00"
generated_at: "2026-05-23T23:49:59.550752+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001714899-25-000077
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-04-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000077/0001714899-25-000077-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000077/dnli-20250402.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000077
- JSON: https://secwatch.observer/filing/0001714899-25-000077.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000077.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.