secwatch.observer — SEC 8-K summary
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Issuer:     ACHIEVE LIFE SCIENCES, INC. (ACHV)
CIK:        0000949858
Form:       8-K
Filed at:   2026-03-24T23:59:59+00:00
Accession:  0001193125-26-120687
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/949858/000119312526120687/0001193125-26-120687-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/949858/000119312526120687/achv-20260324.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-120687

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer