FDA Priority Voucher for Vaping Indication
Achieve Life Sciences received a Commissioner's National Priority Voucher from the FDA for cytisinicline in vaping cessation, allowing for expedited NDA review and potential early market entry.
Regulatory Milestones Achieved
FDA accepted the NDA for cytisinicline for smoking cessation with a PDUFA date set for June 20, 2026. A 120-day safety review was also submitted on time.
Positive Outcomes from COPD Studies
Smokers with COPD had higher quit rates on cytisinicline compared to placebo in Phase III trials, indicating cytisinicline's potential to aid a difficult-to-treat population.
Commercial Strategy and AI Integration
Achieve is integrating AI-driven tools for precision targeting in its commercialization strategy, enhancing engagement and optimizing resource allocation.
Strong Financial Position
As of September 30, 2025, Achieve had $48.1 million in cash, cash equivalents, and marketable securities, with a cash runway extending into the second half of 2026.