---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000180"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-10-14T23:59:59+00:00"
generated_at: "2026-05-17T03:55:01.515884+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA extends Denali's PDUFA date for tividenofusp alfa to April 5, 2026

## Summary
- FDA extended PDUFA target date from Jan 5 to April 5, 2026 for tividenofusp alfa BLA for Hunter syndrome.
- Extension follows submission of updated clinical pharmacology info; FDA classified as Major Amendment.
- Denali states extension not related to efficacy, safety, or biomarkers; no additional data requested.
- Denali continues preparing for potential approval and commercial launch of tividenofusp alfa.

## SEC filing metadata
- accession: 0001714899-25-000180
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-10-14T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000180/0001714899-25-000180-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000180/dnli-20251013.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000180
- JSON: https://secwatch.observer/filing/0001714899-25-000180.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000180.txt

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