---
schema_version: "secwatch.filing_event.v1"
accession: "0001714899-25-000209"
form_type: "8-K"
ticker: "DNLI"
cik: "0001714899"
company_name: "Denali Therapeutics Inc."
filed_at: "2025-12-04T23:59:59+00:00"
generated_at: "2026-05-16T14:51:02.995577+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Denali pipeline update: DNL952 on clinical hold; PDUFA date Apr 2026 for Hunter syndrome

## Summary
- BLA for tividenofusp alfa (Hunter syndrome) under FDA review; PDUFA target action date April 5, 2026. Enrollment in Cohort A expected to complete Dec 2025.
- DNL126 (MPS IIIA) Phase 1/2 on track for completion 2026; potential accelerated approval and commercial launch by end of 2027. Initial data at 2026 WORLD Symposium.
- IND for DNL952 (Pompe) placed on clinical hold; FDA requested protocol amendments (lower starting dose, revised inclusion criteria). Denali has responded, minimal delays expected.
- Phase 1b study of DNL628 (Alzheimer's) expected to begin 1H 2026; CTA submitted. Regulatory submission for DNL921 planned 1H 2026.
- BIIB122 (Parkinson's) Phase 2b readout expected 2026. Eclitasertib (ulcerative colitis) Phase 2 data expected 1H 2026.

## SEC filing metadata
- accession: 0001714899-25-000209
- form_type: 8-K
- ticker: DNLI
- cik: 0001714899
- company_name: Denali Therapeutics Inc.
- filed_at: 2025-12-04T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000209/0001714899-25-000209-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1714899/000171489925000209/dnli-20251204.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001714899-25-000209
- JSON: https://secwatch.observer/filing/0001714899-25-000209.json
- Plain text: https://secwatch.observer/filing/0001714899-25-000209.txt

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