---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-069392"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2023-12-11T23:59:59+00:00"
generated_at: "2026-06-07T15:22:17.662927+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Achieve Life Sciences: FDA requires long-term safety data; NDA filing likely delayed

## Summary
- FDA supports NDA on two Phase 3 trials but demands long-term safety data beyond 12 weeks for chronic-use label.
- Company expects further FDA input in Q1 2024; NDA submission timing may be delayed.
- Long-term safety data may be collected from cumulative treatment and vaping cessation program.
- Single drug candidate cytisinicline at risk; delay could impact regulatory timeline.

## SEC filing metadata
- accession: 0000950170-23-069392
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2023-12-11T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000095017023069392/0000950170-23-069392-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000095017023069392/achv-20231211.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-069392
- JSON: https://secwatch.observer/filing/0000950170-23-069392.json
- Plain text: https://secwatch.observer/filing/0000950170-23-069392.txt

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