ACHV · Achieve Life Sciences, Inc.

Summary

Achieve Life Sciences announced Q4 and full year 2025 financial results, reporting net losses of $14.7 million and $54.7 million, respectively, with $36.4 million in cash as of December 31, 2025. Updates include FDA acceptance of cytisinicline NDA with PDUFA date of June 20, 2026, completion of ORCA-OL trial, and partnership with Adare Pharma Solutions for U.S. manufacturing ahead of potential 2027 launch.

Key takeaways

• Cash, cash equivalents, and marketable securities: $36.4 million as of December 31, 2025
• Q4 2025 net loss: $14.7 million (vs. $12.4 million in Q4 2024)
• Full year 2025 net loss: $54.7 million (vs. $39.8 million in 2024)
• Cytisinicline NDA PDUFA target: June 20, 2026
• ORCA-OL trial completed with 334 participants
• Partnership with Adare Pharma Solutions for cytisinicline manufacturing; technology transfer commenced
• Anticipated U.S. commercial launch: first half of 2027