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.

View on SEC.gov

51 earnings releases filed in the last 30 days. Browse all earnings releases →

ACHIEVE LIFE SCIENCES, INC. filing history →

Source: SEC EDGAR

accession 0001193125-26-120687

view filing index on sec.gov

view primary document

Machine-readable: JSON · Markdown · Plain text

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.