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

ACHIEVE LIFE SCIENCES, INC.

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.

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.85

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

Exact text from the filing

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.

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ACHIEVE LIFE SCIENCES, INC. filing history →

Source: SEC EDGAR

accession 0001193125-26-120687

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