secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2025-11-06T23:59:59+00:00
Accession:  0001714899-25-000192
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489925000192/0001714899-25-000192-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489925000192/dnli-20251106.htm
  HTML page:      https://secwatch.observer/filing/0001714899-25-000192

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