Achieve Life Sciences, Inc. (ACHV) will present the first public release of its pooled Phase 3 efficacy and safety data for cytisinicline at the Society for Research on Nicotine & Tobacco (SRNT) 2026 Annual Meeting in Baltimore, Maryland. The presentation will cover 1,602 participants from the ORCA‑2 and ORCA‑3 trials, highlighting quit rates among patients with extensive prior treatment exposure and varying numbers of quit attempts.
The company will also share late‑breaking survey results from the ORCA‑OL open‑label, long‑term safety study, which followed participants for up to one year of cytisinicline use. The data will provide insights into patient experience and extended use outcomes, complementing the Phase 3 efficacy findings.
The presentation is scheduled for March 5 2026 (poster session, 11:30 AM–1:00 PM EST) and March 6 2026 (oral session, 8:45 AM–9:00 AM EST) during the SRNT 2026 Annual Meeting, which runs from March 4–7.
By presenting these results, Achieve aims to strengthen the evidence base for cytisinicline’s efficacy and tolerability profile ahead of the FDA’s June 20 2026 PDUFA review date. The new data could influence the agency’s assessment and accelerate the drug’s path to market, making the announcement a material event for investors and stakeholders.
"The FDA's acceptance of our NDA for cytisinicline in smoking cessation is an important milestone for Achieve, reflecting the strength of our clinical development program," said CEO Rick Stewart. "The vaping cessation market represents a significant and growing unmet medical need, with approximately 60% of the 17 million adult e-cigarette users in the United States expressing a desire to quit."
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