Achieve Advanced Cytisinicline Manufacturing, Targets NDA Resubmission In 2026

Achieve Life Sciences has announced key operational progress for cytisinicline, its investigational treatment for nicotine dependence, including the successful transfer of manufacturing to Adare Pharma Solutions in the United States. The company has completed the analytical method transfer to Adare’s facility in Ohio, ensuring all testing procedures meet required quality and regulatory standards.

Achieve also confirmed that the first engineering batch of cytisinicline has been produced at the Adare site. This milestone represents an important step toward commercial manufacturing scale-up and supports future regulatory submissions.

“The completion of the analytical transfer and the first batch now in the manufacturing site firmly positions Achieve to meet the goal of manufacturing cytisinicline drug product in the U.S.,” said Rick Stewart, Chief Executive Officer of Achieve Life Sciences. “This rapid progress reflects the sense of urgency for a strong domestic supply chain, given the significant tariffs recently announced on imported pharmaceutical products and the growing imperative for supply chain resilience.”

Previously, the U.S. Food and Drug Administration had issued observations following a current Good Manufacturing Practice (cGMP) inspection at a third-party facility, which received an Official Action Indicated (OAI) classification. The company clarified that these issues were related to general manufacturing practices and were not specific to cytisinicline.

“We are excited to have partnered with Achieve, reflecting our shared commitment to advancing transformative therapies and delivering meaningful impact for patients in need,” said Tom Sellig, Chief Executive Officer of Adare Pharma Solutions and member of the Achieve Board of Directors since 2023. “We are proud of what we have accomplished together thus far, and we remain deeply committed to supporting Achieve as their cytisinicline program progresses toward making a difference in patients’ lives.”

Achieve expects to receive a Complete Response Letter from the FDA by its June 20, 2026 PDUFA date and plans to resubmit its New Drug Application in the fourth quarter of 2026, naming Adare as the commercial manufacturer. The company continues to target a potential launch of cytisinicline in the first half of 2027.