secwatch.observer — SEC 8-K summary
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Issuer:     Denali Therapeutics Inc. (DNLI)
CIK:        0001714899
Form:       8-K
Filed at:   2026-02-26T23:59:59+00:00
Accession:  0001714899-26-000020
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Denali Q4 2025 net loss $128.5M; tividenofusp alfa PDUFA date April 5, 2026
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- Q4 2025 net loss $128.5M vs $114.8M in Q4 2024; full year net loss $512.5M vs $422.8M in 2024.
- PDUFA target action date for tividenofusp alfa (Hunter syndrome) BLA is April 5, 2026; commercial launch readiness established.
- Preliminary Phase 1/2 data for DNL126 (Sanfilippo syndrome type A) support accelerated approval path; global Phase 3 planning ongoing.
- Cash, cash equivalents and marketable securities as of Dec 31, 2025 were approximately $966.2M.
- In December 2025, raised $275M synthetic royalty from Royalty Pharma and ~$200M net from public offering.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000020/0001714899-26-000020-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1714899/000171489926000020/dnli-20260226.htm
  HTML page:      https://secwatch.observer/filing/0001714899-26-000020

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