secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2025-12-04T23:59:59+00:00
Accession:  0001714899-25-000209
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489925000209/0001714899-25-000209-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489925000209/dnli-20251204.htm
  HTML page:      https://secwatch.observer/filing/0001714899-25-000209

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