secwatch.observer — SEC 8-K summary
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Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2023-05-23T23:59:59+00:00
Accession:  0000950170-23-023533
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Achieve Life Sciences reports positive Phase 3 ORCA-3 data; 12-week cytisinicline 30.3% quit rate vs 9.4% placebo
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- 12-week cytisinicline: 30.3% quit rate last 4 wks, 4.4x odds vs placebo (p<0.0001); continuous abstinence wk9-24: 20.5% vs 4.2%
- 6-week cytisinicline: 14.8% quit rate last 4 wks, 2.85x odds vs placebo (p=0.0008); continuous abstinence wk3-24: 6.8% vs 1.1%
- No treatment-related serious adverse events; common side effects: insomnia (11.9% 12-wk), abnormal dreams, nausea, headache
- ORCA-3 enrolled 792 adult smokers at 20 US sites; results consistent with prior Phase 3 ORCA-2 study
- Cytisinicline could be first new prescription smoking cessation treatment in ~20 years; conference call May 23 at 8:30AM EDT

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000095017023023533/0000950170-23-023533-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000095017023023533/achv-20230523.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-023533

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