---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000146"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-07-07T23:59:59+00:00"
generated_at: "2026-05-18T09:17:51.740391+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Denali's BLA for tividenofusp alfa with Priority Review; PDUFA Jan 5, 2026

## Summary
- FDA grants Priority Review for BLA seeking accelerated approval of tividenofusp alfa for Hunter syndrome (MPS II).
- PDUFA target action date set for January 5, 2026.
- Tividenofusp alfa is designed to deliver IDS enzyme across the blood-brain barrier using TransportVehicle platform.
- BLA supported by Phase 1/2 data from 47 participants; ongoing Phase 2/3 COMPASS study for global approvals.
- If approved, would be first new enzyme replacement therapy for Hunter syndrome in nearly two decades.

## SEC filing metadata
- accession: 0001714899-25-000146
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-07-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000146/0001714899-25-000146-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000146/dnli-20250707.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000146
- JSON: https://secwatch.observer/filing/0001714899-25-000146.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000146.txt

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