Achieve Life Sciences, Inc. (ACHV)

In June 2025, Achieve Life Sciences completed a $45.0 million underwritten public offering, leading to share price decline due to dilution. The company submitted its NDA for cytisinicline for smoking cessation to the FDA in June 2025, and the FDA accepted it for review in September 2025, assigning a PDUFA target action date of June 20, 2026. Positive results from the Phase 3 ORCA-3 clinical trial for smoking cessation were published in April 2025. Achieve Life Sciences received the FDA Commissioner's National Priority Voucher for cytisinicline for vaping cessation on October 17, 2025. Erik Atkisson was appointed as Chief Legal Officer on October 20, 2025. On November 3, 2025, the company announced the submission of a safety update to the FDA and the successful conclusion of the ORCA-OL long-term safety trial. Achieve Life Sciences reported a net loss of $(14.4) million for the third quarter of 2025 on November 6, 2025. Analysts initiated coverage with positive ratings in August and November 2025. There has been significant insider selling over the past 90 days.

There is no explicit information available indicating demand seasonality for Achieve Life Sciences, Inc.'s products or services. The demand for cytisinicline is unlikely to be subject to significant seasonal fluctuations.

Achieve Life Sciences, Inc. is a specialty pharmaceutical company focused on addressing smoking and nicotine addiction. It operates in the Healthcare sector and Biotechnology industry, developing and commercializing cytisinicline, a plant-based alkaloid that helps individuals achieve nicotine independence by interacting with nicotine receptors in the brain to reduce withdrawal symptoms. Cytisinicline is being developed for both smoking and vaping cessation.

Achieve Life Sciences, Inc. develops and commercializes cytisinicline in Canada, the United States, and the United Kingdom. The company's headquarters are located in Bothell, Washington, in the United States, and it also maintains an office in Vancouver, British Columbia, Canada.

Achieve Life Sciences' brand reputation has been shaped by advancements in its cytisinicline program and market perceptions. Positive clinical trial results, FDA acceptance of the NDA, and receipt of an FDA voucher have positively impacted its scientific and regulatory standing. Analyst initiations with positive ratings also indicate a positive outlook. However, the public offering and insider selling could have introduced investor caution.

Achieve Life Sciences, Inc. has a diverse ownership structure with 29.18% held by institutional shareholders, 19.49% by insiders, and 51.33% by retail investors. Major institutional owners include Propel Bio Management, LLC, Vanguard Group Inc, Simplify Asset Management Inc., Marshall Wace, Llp, Nantahala Capital Management, LLC, and Franklin Advisers, Inc. Dialectic Capital Management LP is the largest individual shareholder, owning 3.55 million shares, representing 6.67% of the company.