Achieve Life Sciences Schedules March 24 Earnings Call, June 20 PDUFA for Cytisinicline
Achieve Life Sciences will report fourth quarter and full-year 2025 results and host a conference call on March 24, 2026 at 8:30 AM EDT. The FDA set a June 20, 2026 PDUFA deadline for its cytisinicline NDA, accepted in September 2025 after two Phase 3 trials.
1. Earnings Release and Conference Call
Achieve Life Sciences will release its fourth quarter and full-year 2025 financial results on March 24, 2026 at 8:30 AM EDT. Investors can join the live conference call via dial-in or webcast, with a replay available on the company's website for 90 days.
2. FDA Review and PDUFA Date
The New Drug Application for cytisinicline was accepted for FDA review in September 2025 and carries a Prescription Drug User Fee Act date of June 20, 2026. This deadline marks the agency’s target for a decision on its smoking cessation indication.
3. Cytisinicline Clinical Progress
Cytisinicline’s NDA is supported by two completed Phase 3 trials and an open-label safety study demonstrating efficacy in nicotine dependence. The company has also completed a Phase 2 vaping cessation study and held an end-of-Phase 2 meeting with the FDA regarding a future vaping indication.
4. Market Potential and Next Steps
Approximately 25 million U.S. adults smoke combustible cigarettes and 18 million use e-cigarettes, with no FDA-approved vaping cessation treatments. Achieve plans to discuss commercialization strategies and next steps for cytisinicline following the upcoming FDA decision.