secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2025-10-14T23:59:59+00:00
Accession:  0001714899-25-000180
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends Denali's PDUFA date for tividenofusp alfa to April 5, 2026
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- FDA extended PDUFA target date from Jan 5 to April 5, 2026 for tividenofusp alfa BLA for Hunter syndrome.
- Extension follows submission of updated clinical pharmacology info; FDA classified as Major Amendment.
- Denali states extension not related to efficacy, safety, or biomarkers; no additional data requested.
- Denali continues preparing for potential approval and commercial launch of tividenofusp alfa.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489925000180/0001714899-25-000180-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489925000180/dnli-20251013.htm
  HTML page:      https://secwatch.observer/filing/0001714899-25-000180

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