Achieve Life Sciences ( (ACHV) ) has released its Q3 earnings. Here is a breakdown of the information Achieve Life Sciences presented to its investors.
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Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline, a treatment for nicotine dependence, operating within the pharmaceutical industry with a unique focus on smoking and vaping cessation therapies.
In its latest earnings report, Achieve Life Sciences announced its third-quarter 2025 financial results and provided updates on its cytisinicline program, highlighting significant regulatory milestones and strategic advancements. The company confirmed the FDA’s acceptance of its New Drug Application for cytisinicline aimed at smoking cessation, with a targeted action date set for June 2026.
Key highlights from the report include the FDA’s acceptance of the cytisinicline NDA for smoking cessation and the awarding of the FDA Commissioner’s National Priority Voucher for vaping cessation. Achieve also published new data in Thorax, demonstrating improved smoking quit rates in adults with COPD, and completed several milestones in advancing the cytisinicline NDA, including safety updates and trial completions. Financially, the company reported a net loss of $14.4 million for the third quarter, with operating expenses totaling $14.7 million.
The appointment of Erik Atkisson as Chief Legal Officer was also announced, bringing significant legal expertise to the company’s leadership team as it prepares for potential commercialization of cytisinicline. Achieve’s financial position includes $48.1 million in cash and marketable securities, supporting its ongoing development efforts.
Looking ahead, Achieve Life Sciences remains focused on advancing cytisinicline through regulatory review and preparing for its potential commercialization, aiming to address the unmet medical needs in nicotine dependence treatment for both smoking and vaping cessation.