---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-120687"
form_type: "8-K"
ticker: "ACHV"
cik: "0000949858"
company_name: "ACHIEVE LIFE SCIENCES, INC."
filed_at: "2026-03-24T23:59:59+00:00"
generated_at: "2026-05-15T09:18:55.117421+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Achieve Life Sciences reports Q4/FY2025 net loss $54.7M; cytisinicline NDA PDUFA June 20, 2026

## Summary
- Cash $36.4M at Dec 31, 2025; net loss $14.7M Q4 and $54.7M FY2025.
- FDA accepted cytisinicline NDA for smoking cessation; PDUFA action date June 20, 2026.
- Partnered with Adare Pharma Solutions for US-based manufacturing; tech transfer begun.
- Anticipates US commercial launch in first half 2027.
- Completed ORCA-OL one-year safety study with 334 participants.

## SEC filing metadata
- accession: 0001193125-26-120687
- form_type: 8-K
- ticker: ACHV
- cik: 0000949858
- company_name: ACHIEVE LIFE SCIENCES, INC.
- filed_at: 2026-03-24T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/949858/000119312526120687/0001193125-26-120687-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/949858/000119312526120687/achv-20260324.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-120687
- JSON: https://secwatch.observer/filing/0001193125-26-120687.json
- Plain text: https://secwatch.observer/filing/0001193125-26-120687.txt

## Key facts
- Earnings Releases
  ACHIEVE LIFE SCIENCES, INC. reported the fourth quarter and full year ended December 31, 2025 results: net income Total net loss for the three and twelve months ended December 31, 2025, was $14.7 million and $54.7 million, respectivel.
  - Period: the fourth quarter and full year ended December 31, 2025
  - Net income: Total net loss for the three and twelve months ended December 31, 2025, was $14.7 million and $54.7 million, respectivel
  - Result: reported results
  source text: On March 24, 2026, Achieve Life Sciences, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2025.
  evidence_url: https://www.sec.gov/Archives/edgar/data/949858/000119312526120687/0001193125-26-120687-index.htm

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