secwatch.observer — SEC 8-K summary
======================================

Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2023-01-09T23:59:59+00:00
Accession:  0001714899-23-000008
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Denali outlines 2023 milestones: four late-stage programs, IND for DNL126, OTV expansion
--------------------------------------------------------------------------------

- Four programs expected in late-stage: DNL310 (MPS II), BIIB122 (Parkinson's), SAR443820 (ALS), DNL343 ALS Phase 2/3
- DNL126 (ETV:SGSH) for MPS IIIA: IND submission H1 2023, Phase 1/2 recruitment H2 2023
- Oligonucleotide TV platform: five ASO targets selected; two OTV candidates advancing toward clinic
- DNL343 (eIF2B activator) ALS: final Phase 1b data mid-2023; Phase 2/3 in HEALEY Platform Trial mid-2023

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489923000008/0001714899-23-000008-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489923000008/dnli-20230109.htm
  HTML page:      https://secwatch.observer/filing/0001714899-23-000008

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