secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2026-01-06T23:59:59+00:00
Accession:  0001714899-26-000004
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Denali outlines 2026 milestones: PDUFA April 5 for Hunter syndrome, multiple pipeline readouts
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- Preparing for commercial launch of tividenofusp alfa (Hunter syndrome) with PDUFA target action date April 5, 2026; results published in NEJM.
- Expect multiple clinical data readouts: Phase 1/2 DNL126 for Sanfilippo type A, Phase 1/2 DNL593 for FTD-GRN, Phase 2b LUMA for Parkinson's (BIIB122).
- Initiate Phase 1b for DNL628 (OTV:MAPT) in Alzheimer's; FDA lifted clinical hold on DNL952 for Pompe disease; Phase 1 start.
- Completed equity financing (~$200M gross) and royalty funding from Royalty Pharma up to $275M; cash as of Sep 30, 2025: ~$872.9M.
- Partnerships: Biogen (Parkinson's, 50/50 US), Takeda (FTD-GRN, 50/50 US), Sanofi (RIPK1 inhibitor in UC, royalties).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000004/0001714899-26-000004-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000004/dnli-20260106.htm
  HTML page:      https://secwatch.observer/filing/0001714899-26-000004

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer