Achieve Life Sciences Inc. (NASDAQ:ACHV) reported fourth-quarter results that matched analyst forecasts, posting a loss of -$0.28 per share, in line with the consensus estimate of -$0.28.
The company’s shares were unchanged in pre-market trading following the announcement.
The late-stage pharmaceutical company, which is developing cytisinicline as a treatment for nicotine dependence, reported a net loss of $14.7 million for the three months ended December 31, 2025, compared with a net loss of $12.4 million in the same quarter a year earlier. For the full year 2025, Achieve recorded a net loss of $54.6 million. Total operating expenses for the fourth quarter rose to $14.7 million from $12.2 million in the prior-year period.
Achieve also announced a new manufacturing partnership with U.S.-based Adare Pharma Solutions to produce cytisinicline drug product. The collaboration is intended to lower manufacturing costs and reduce risks tied to international pharmaceutical imports, including potential tariffs.
The company said it has begun transferring manufacturing technology to Adare and expects to launch the treatment commercially in the United States during the first half of 2027.
“Achieve is fully committed to bringing cytisinicline to the millions of people who continue to struggle with nicotine dependence and need a new solution to help them quit,” said Rick Stewart, President and Chief Executive Officer.
Achieve also reported progress toward regulatory approval. The U.S. Food and Drug Administration has accepted the company’s New Drug Application for cytisinicline and set a PDUFA target action date of June 20, 2026.
The company completed its ORCA-OL long-term exposure study, with 334 participants finishing the one-year trial. Cytisinicline was also selected as one of nine therapies included in the FDA Commissioner’s National Priority Voucher program for treatments targeting e-cigarette or vaping cessation.
As of December 31, 2025, Achieve reported cash, cash equivalents and marketable securities totaling $36.4 million.