Achieve Life Sciences announced significant operational progress including the transfer of cytisinicline manufacturing to Adare Pharma Solutions. Achieve has now completed the analytical method transfer to Adare’s manufacturing facility in Vandalia, Ohio. Completion of these activities ensures that all testing procedures are fully qualified at the site, maintaining the highest standards of quality control and regulatory compliance.
Achieve confirms that its first cytisinicline engineering batch has been manufactured at Adare. This initial manufacturing run is a vital precursor to registration and, ultimately, production at commercial scales and volumes.
“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.”
“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.”
As previously disclosed, the U.S. Food and Drug Administration (FDA) identified observations during a current Good Manufacturing Practice (cGMP) inspection of the Company’s third-party manufacturing facility. Achieve has recently been informed that the facility received an Official Action Indicated (OAI) classification from that inspection. The observations resulting in the OAI classification relate to general cGMP matters at the facility and are not specific to cytisinicline.
Achieve expects to receive a Complete Response Letter from the FDA on or before its June 20, 2026 Prescription Drug User Fee Act goal date. The Company intends to resubmit the New Drug Application naming Adare Pharma Solutions as its manufacturer for commercial supply in the fourth quarter of 2026. The Company reiterates its expectation of a cytisinicline launch in the first half of 2027.