---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-26-000020"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2026-02-26T23:59:59+00:00"
generated_at: "2026-05-15T23:41:38.611224+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Denali Q4 2025 net loss $128.5M; tividenofusp alfa PDUFA date April 5, 2026

## Summary
- Q4 2025 net loss $128.5M vs $114.8M in Q4 2024; full year net loss $512.5M vs $422.8M in 2024.
- PDUFA target action date for tividenofusp alfa (Hunter syndrome) BLA is April 5, 2026; commercial launch readiness established.
- Preliminary Phase 1/2 data for DNL126 (Sanfilippo syndrome type A) support accelerated approval path; global Phase 3 planning ongoing.
- Cash, cash equivalents and marketable securities as of Dec 31, 2025 were approximately $966.2M.
- In December 2025, raised $275M synthetic royalty from Royalty Pharma and ~$200M net from public offering.

## SEC filing metadata
- accession: 0001714899-26-000020
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2026-02-26T23:59:59+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/1714899/000171489926000020/0001714899-26-000020-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489926000020/dnli-20260226.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-26-000020
- JSON: https://secwatch.observer/filing/0001714899-26-000020.json
- Plain text: https://secwatch.observer/filing/0001714899-26-000020.txt

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