8legs: Achieve life sciences, inc.

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Achieve Life Sciences 2025 10-K: Net loss $54.6M, EPS $(1.25)

Achieve Life Sciences reports a 2025 net loss of $54.6 million and a per-share loss of $1.25.
Cash holdings at year end totaled $36.4 million, with ongoing concerns about the company’s ability to continue as a going concern.
A June 20, 2026 PDUFA date was set for the NDA of cytisinicline for smoking cessation.
Breakthrough Therapy designation and CNPV support FDA engagement for faster review.
U.S. manufacturing partnership with Adare and technology transfer underway for a 2027 US launch.
ORCA-OL trial completed in September 2025; safety and efficacy data continue to support regulatory progress.
2025 operating spend increased to support anticipated commercialization activities.
NDA for cytisinicline advanced as regulatory momentum grows for smoking cessation and vaping indications.
No revenue figure disclosed for 2025 in the 10-K filing.
Company disclosed substantial doubt about continuing as a going concern.

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