---
schema_version: "secwatch.filing_event.v1"
accession: "0001564590-22-015873"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2022-04-27T23:59:59+00:00"
generated_at: "2026-06-26T04:26:41.749977+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Achieve Life Sciences reports positive Phase 3 ORCA-2 results; cytisinicline shows 6-8x odds of smoking abstinence

## Summary
- Primary endpoints met: 12-week cytisinicline had 32.6% abstinence vs 7.0% placebo (OR 6.3, p<0.0001); 6-week had 25.3% vs 4.4% (OR 8.0, p<0.0001).
- Secondary continuous abstinence weeks 9-24: 21.1% for 12-week arm vs 4.8% placebo (OR 5.3, p<0.0001); weeks 3-24: 8.9% vs 2.6% (OR 3.7, p=0.0016).
- Well tolerated; no treatment-related serious adverse events. Most common AEs (>5%): insomnia, abnormal dreams, headache, nausea.
- SVB approved remaining $10M of $25M debt facility; terms: interest at greater of 3.5% or WSJ prime, interest-only through Apr 2024, then 24-month amortization.
- Facility available through Apr 30, 2023; no amounts drawn at close; discretionary draws allowed.

## SEC filing metadata
- accession: 0001564590-22-015873
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2022-04-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 1.01, 2.03, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000156459022015873/0001564590-22-015873-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000156459022015873/achv-8k_20220426.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001564590-22-015873
- JSON: https://secwatch.observer/filing/0001564590-22-015873.json
- Plain text: https://secwatch.observer/filing/0001564590-22-015873.txt

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