regulatory
confidence high
sentiment positive
materiality 0.75
ACHV Q3 net loss $14.4M; FDA accepts cytisinicline NDA, PDUFA June 20, 2026
ACHIEVE LIFE SCIENCES, INC.
- Net loss $14.4M for Q3 2025; cash, equivalents & marketable securities $48.1M at Sep 30.
- FDA accepted cytisinicline NDA for smoking cessation; PDUFA target action date June 20, 2026.
- FDA awarded Commissioner’s National Priority Voucher for vaping cessation, enabling 1-2 month expedited review.
- Appointed Erik Atkisson as Chief Legal Officer; over 25 years biopharma legal experience.
- New post hoc data in Thorax shows cytisinicline improved quit rates in adults with COPD.