---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-26-000030"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2026-03-25T23:59:59+00:00"
generated_at: "2026-05-15T09:02:11.965398+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Denali Therapeutics receives FDA approval for AVLAYAH in Hunter syndrome

## Summary
- FDA grants accelerated approval for AVLAYAH (tividenofusp alfa) to treat neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients ≥5 kg.
- First FDA-approved biologic designed to cross the blood-brain barrier using TransportVehicle platform.
- Approval based on 91% reduction in CSF heparan sulfate biomarker at week 24; 93% of patients reached normal range.
- Most common adverse reaction: infusion-related reactions; continued approval contingent on confirmatory COMPASS trial.
- FDA awarded Rare Pediatric Disease Priority Review Voucher (PRV) in connection with approval.

## SEC filing metadata
- accession: 0001714899-26-000030
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2026-03-25T23:59:59+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/1714899/000171489926000030/0001714899-26-000030-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489926000030/dnli-20260325.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-26-000030
- JSON: https://secwatch.observer/filing/0001714899-26-000030.json
- Plain text: https://secwatch.observer/filing/0001714899-26-000030.txt

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