secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2023-06-20T23:59:59+00:00
Accession:  0001714899-23-000103
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Denali reports 64% reduction in NfL with DNL310 in MPS II after 2 years
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- Mean serum NfL reduction of 64% (p<0.001) from baseline at 2 years in Phase 1/2 study (n=13).
- FDA recommended assessment of NfL as a possible biomarker in neuronopathic MPS II.
- Additional interim data from Phase 1/2 to be presented at SSIEM symposium in August 2023.
- Global Phase 2/3 COMPASS study of DNL310 ongoing; management hosted investor webinar June 20.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489923000103/0001714899-23-000103-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489923000103/dnli-20230620.htm
  HTML page:      https://secwatch.observer/filing/0001714899-23-000103

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