---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-268056"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2025-11-06T23:59:59+00:00"
generated_at: "2026-05-17T00:08:30.431442+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# ACHV Q3 net loss $14.4M; FDA accepts cytisinicline NDA, PDUFA June 20, 2026

## Summary
- Net loss $14.4M for Q3 2025; cash, equivalents & marketable securities $48.1M at Sep 30.
- FDA accepted cytisinicline NDA for smoking cessation; PDUFA target action date June 20, 2026.
- FDA awarded Commissioner’s National Priority Voucher for vaping cessation, enabling 1-2 month expedited review.
- Appointed Erik Atkisson as Chief Legal Officer; over 25 years biopharma legal experience.
- New post hoc data in Thorax shows cytisinicline improved quit rates in adults with COPD.

## SEC filing metadata
- accession: 0001193125-25-268056
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2025-11-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000119312525268056/0001193125-25-268056-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000119312525268056/achv-20251106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-268056
- JSON: https://secwatch.observer/filing/0001193125-25-268056.json
- Plain text: https://secwatch.observer/filing/0001193125-25-268056.txt

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