secwatch.observer — SEC 8-K summary
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Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2025-02-10T23:59:59+00:00
Accession:  0000950170-25-017068
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Achieve DSMC finds no safety concerns in ORCA-OL; NDA on track for Q2 2025
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- DSMC completed second independent review of ORCA-OL trial; no unexpected treatment-related adverse events identified.
- Participants' adherence to cytisinicline was excellent; study continues as planned without modifications.
- Achieve reiterates planned New Drug Application submission for cytisinicline in Q2 2025.
- ORCA-OL enrolled 479 participants across 29 US sites; 300+ completed six months of cumulative cytisinicline treatment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000095017025017068/0000950170-25-017068-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000095017025017068/achv-20250210.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-017068

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