Smoking Cessation Drug Developer Faces FDA Supplementary Requests Despite Securing Billions in Private Investment

Achieve Life Sciences, Inc. (Nasdaq: ACHV), which is developing the nicotine-dependence therapy cytisinicline, announced on May 12 that it has closed a private placement of up to $354 million (approximately KRW 480 billion), securing about $180 million (around KRW 250 billion) as an upfront payment. The company’s existing contract manufacturing facility has received an “Official Action Indicated” rating from the FDA under current Good Manufacturing Practices, and Achieve expects to receive a Complete Response Letter by the June 20 PDUFA date. At the same time, Achieve named U.S.-based Adare Pharma Solutions as its new primary commercial manufacturing partner, with plans to resubmit the New Drug Application for cytisinicline in Q4 2026 and target a U.S. launch in H1 2027. The company also reorganized its board and commercial leadership—appointing Dr. Andrew D. Goldberg as CEO and director—and reported approximately $30 million (KRW 40 billion) in cash and cash equivalents at quarter end, with quarterly operating expenses and net loss each in the low-$10 million range.

On May 19, Achieve presented 52-week continuous-dosing safety data for cytisinicline at a scientific conference, and on June 2 appointed Jeffrey Farrow and Dr. Reid Waldman to its board to strengthen its commercial strategy, financial oversight, and clinical expertise as it prepares for potential FDA approval and market launch.

Achieve Life Sciences is a late-stage specialty pharmaceutical company listed on Nasdaq. Its plant-derived cytisinicline is being developed as a prescription treatment for adult smoking and vaping cessation. If approved, it would be the first new prescription smoking-cessation drug in more than 20 years. Given the limitations of existing nicotine-replacement therapies and oral treatments, the nicotine-dependence market driven by smoking and vaping represents a major unmet need—and the entry of a novel therapy could cause substantial market shifts depending on regulatory and reimbursement frameworks.