Achieve Life Sciences (NASDAQ:ACHV) today reported its financial results for the fourth quarter and full year ended December 31, 2025, alongside a series of transformative regulatory and operational updates for its lead smoking cessation candidate, cytisinicline.
The company confirmed that the U.S. Food and Drug Administration (FDA) has formally accepted its New Drug Application (NDA), establishing a PDUFA (Prescription Drug User Fee Act) action date of June 20, 2026.
This milestone positions Achieve on the verge of bringing the first new prescription smoking cessation treatment to the U.S. market in nearly two decades.
The clinical foundation for the filing was further solidified by the completion of the ORCA-OL study.
This open-label safety trial, which enrolled 334 participants, provided the necessary year-long exposure data required by the FDA to evaluate the long-term safety profile of cytisinicline.
Beyond the clinic, Achieve has moved aggressively to secure its supply chain, announcing a strategic manufacturing partnership with Adare Pharma Solutions.
This U.S.-based collaboration is designed to scale production to meet the anticipated demand of a planned commercial launch in the first half of 2027.
Financially, Achieve remains focused on extending its runway through the upcoming regulatory decision.
As of December 31, 2025, the company reported $36.4 million in cash and marketable securities.
The net loss for the full year 2025 was $54.7 million, largely driven by $54.9 million in operating expenses associated with the finalization of the ORCA clinical program and the intensive NDA preparation process.
During the March 24, 2026 conference call, management indicated that current capital, combined with potential strategic financing options, is intended to support operations through the PDUFA date.