Achieve Life Sciences Sets March 24, 2026, for 2025 Financial Results and Cytisinicline Update — Achieve Life Sciences, Inc.

Event summary

Achieve Life Sciences will report Q4 and full-year 2025 financial results on March 24, 2026, at 8:30 AM EDT.
The company's New Drug Application (NDA) for cytisinicline was accepted by the FDA in September 2025, with a PDUFA date of June 20, 2026.
Cytisinicline is being developed for smoking cessation and has completed Phase 3 studies and an open-label safety study.
The company has also completed a Phase 2 study for vaping cessation and held a successful end-of-Phase 2 meeting with the FDA.

The big picture

Achieve Life Sciences is at a critical juncture with its cytisinicline program, awaiting FDA approval for smoking cessation while exploring vaping cessation. The company's success hinges on regulatory outcomes and its ability to penetrate a market with significant unmet needs, given the high prevalence of smoking and vaping. The upcoming financial results and corporate update will provide insights into the company's strategic direction and operational progress.

What we're watching

Regulatory Approval: Whether the FDA will approve cytisinicline for smoking cessation by the PDUFA date of June 20, 2026.
Market Potential: The pace at which Achieve Life Sciences can commercialize cytisinicline if approved, given the large market of smokers and vapers.
Clinical Development: How the Phase 2 study results for vaping cessation will influence future regulatory and commercial strategies.