---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-017068"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2025-02-10T23:59:59+00:00"
generated_at: "2026-05-27T00:46:24.447905+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Achieve DSMC finds no safety concerns in ORCA-OL; NDA on track for Q2 2025

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-25-017068
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2025-02-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000095017025017068/0000950170-25-017068-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000095017025017068/achv-20250210.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-017068
- JSON: https://secwatch.observer/filing/0000950170-25-017068.json
- Plain text: https://secwatch.observer/filing/0000950170-25-017068.txt

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