05:00 PM EDT, 06/26/2025 (MT Newswires) -- Achieve Life Sciences ( ACHV ) said Thursday it submitted a new drug application to the US Food and Drug Administration for cytisinicline as a treatment for nicotine dependence in smoking cessation.

The application is supported by efficacy and safety data from two phase 3 trials, the company said.

Separately, Achieve said it is collaborating with Omnicom Group ( OMC ) to support the US commercial launch of cytisinicline. Its launch platform, Credera, will leverage Omnicom's ( OMC ) AI-driven marketing technology to improve precision targeting, optimize channel performance, and deepen engagement with patients.

Achieve also said it plans to launch an underwritten public offering of common shares and pre-funded warrants, with a 30-day option for underwriters to purchase up to an additional 15% of the securities offered. Proceeds will support regulatory advancement of cytisinicline and general corporate purposes, according to the company.

Shares of Achieve Life Sciences ( ACHV ) fell nearly 14% in after-hours trading.