---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-104569"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2025-08-07T23:59:59+00:00"
generated_at: "2026-05-17T18:47:11.834268+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 submits cytisinicline NDA to FDA; cash position $55.4M

## Summary
- NDA submitted to FDA in June 2025 for cytisinicline as smoking cessation treatment in adults.
- Raised $49.3M gross from underwritten public offering in June-July 2025; expects runway into H2 2026.
- Partnered with Omnicom for integrated launch strategy, reducing internal commercial buildout costs.
- ORCA-OL safety requirements met: >300 subjects with ≥6 months, >100 with ≥1 year cumulative exposure.
- Q2 2025 net loss $12.7M; operating expenses $12.6M; cash & securities $55.4M as of June 30.

## SEC filing metadata
- accession: 0000950170-25-104569
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2025-08-07T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000095017025104569/0000950170-25-104569-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000095017025104569/achv-20250807.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-104569
- JSON: https://secwatch.observer/filing/0000950170-25-104569.json
- Plain text: https://secwatch.observer/filing/0000950170-25-104569.txt

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