Achieve Life Sciences Secures $354M for Cytisinicline

Achieve Life Sciences (NASDAQ: ACHV), a specialty pharmaceutical company headquartered in Bothell, Washington, has announced a private placement of up to USD 354 million to advance cytisinicline, its plant-derived candidate for nicotine dependence, toward commercial launch and into a Phase III trial for e-cigarette cessation.

The transaction comprises USD 180 million in upfront proceeds, with up to an additional USD 174 million available through milestone-driven warrants exercisable within 20 business days of US FDA approval of cytisinicline. The round was led by Frazier Life Sciences, TPG Life Sciences Innovations, venBio Partners, Paradigm BioCapital Advisors, and Marshall Wace. Additional participants include Coastlands Capital, Dialectic Capital, Janus Henderson Investors, LifeSci Venture Partners, Logos Capital, Propel Bio Partners, Spruce Street Capital, Venrock Healthcare Capital Partners, Vivo Capital, and Wellington Management. Morgan Stanley acted as sole placement agent.

Achieve intends to deploy proceeds toward commercialization of cytisinicline, a planned Phase III study in vaping cessation, and general corporate purposes. The placement is structured at USD 3.635 per share of common stock, with accompanying warrants carrying an exercise price of USD 3.51 per share. Prior to this round, the company raised approximately USD 124.2 million through a registered direct offering and concurrent private placement in early 2024, followed by a USD 45 million underwritten public offering in June 2025.

Cytisinicline is a partial agonist at the α4β2 nicotinic acetylcholine receptor, the receptor subtype through which nicotine exerts its effects in the brain's reward circuitry. The molecule is derived from the seeds of the golden chain tree and has a history of use as a smoking cessation aid in Eastern Europe. Achieve's NDA for cytisinicline in adult smoking cessation, submitted to the US FDA in June 2025 and accepted for review in September 2025, carries a PDUFA date of June 20, 2026. The application is supported by two completed Phase III studies and an open-label safety study. The company has also completed a Phase II study in vaping cessation and held a successful end-of-Phase II meeting with the FDA for that indication, for which the agency has granted Breakthrough Therapy designation and awarded a Commissioner's National Priority Voucher. No FDA-approved treatment currently exists specifically for e-cigarette cessation.

Coinciding with the financing, the company's board appointed Andrew D. Goldberg, MD as Chief Executive Officer, effective upon closing. Goldberg is described as a dual board-certified physician with experience in healthcare investment and commercial strategy. Outgoing CEO Richard Stewart will remain on the board of directors. The closing was expected on April 17, 2026, subject to customary conditions, with a registration statement for resale of the placed securities to be filed within 30 days.

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