---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-023533"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2023-05-23T23:59:59+00:00"
generated_at: "2026-06-14T17:47:16.268461+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Achieve Life Sciences reports positive Phase 3 ORCA-3 data; 12-week cytisinicline 30.3% quit rate vs 9.4% placebo

## Summary
- 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

## SEC filing metadata
- accession: 0000950170-23-023533
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2023-05-23T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000095017023023533/0000950170-23-023533-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000095017023023533/achv-20230523.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-023533
- JSON: https://secwatch.observer/filing/0000950170-23-023533.json
- Plain text: https://secwatch.observer/filing/0000950170-23-023533.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.