---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000054"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-01-13T23:59:59+00:00"
generated_at: "2026-05-28T03:36:42.588854+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Denali tividenofusp alfa gets FDA Breakthrough Therapy; BLA submission in early 2025

## Summary
- FDA granted Breakthrough Therapy Designation for tividenofusp alfa in Hunter syndrome (MPS II) on Jan 7, 2025.
- Denali expects BLA submission under accelerated approval pathway in early 2025; U.S. launch targeted late 2025/early 2026.
- Seeking FDA alignment on accelerated approval for DNL126 in Sanfilippo syndrome after CSF HS normalization in Phase 1/2.
- Cash, equivalents, and marketable securities ~$1.28B as of Sep 30, 2024; cash runway extended into 2028.
- Plan to advance 1–2 TV-enabled programs into clinic per year over next three years across ETV, OTV, ATV.

## SEC filing metadata
- accession: 0001714899-25-000054
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-01-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000054/0001714899-25-000054-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000054/dnli-20250113.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000054
- JSON: https://secwatch.observer/filing/0001714899-25-000054.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000054.txt

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