---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000192"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-11-06T23:59:59+00:00"
generated_at: "2026-05-16T23:50:39.104690+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Denali Q3 net loss $126.9M; tividenofusp alfa PDUFA extended to April 2026

## Summary
- Net loss $126.9M vs $107.2M in Q3 2024; cash $872.9M at Sept 30, 2025.
- FDA extended PDUFA date for tividenofusp alfa BLA from Jan 5 to April 5, 2026; no new data requested.
- Completed enrollment in Phase 1/2 study of DNL126 for MPS IIIA; planning global confirmatory study.
- Submitted CTA for DNL628 (Alzheimer's) and IND for DNL952 (Pompe); new pipeline programs.
- CMO Carole Ho departing; Peter Chin appointed Acting CMO; Tim Van Hauwermeiren joins Board.

## SEC filing metadata
- accession: 0001714899-25-000192
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-11-06T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000192/0001714899-25-000192-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000192/dnli-20251106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000192
- JSON: https://secwatch.observer/filing/0001714899-25-000192.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000192.txt

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