Achieve Life Sciences (ACHV) Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025 summary

Company and product background

• Cytisinicline, a partial agonist of the alpha-4 beta-2 receptor, was redesigned to improve efficacy, safety, and compliance, targeting nicotine dependence globally.

• The drug has a long history of use in Central and Eastern Europe and is positioned as the first new treatment for nicotine dependence in nearly 20 years.

• Smoking causes about 500,000 deaths annually in the U.S., with $300 billion in related costs.

• NDA filing with the FDA is planned for next quarter.

Clinical data and efficacy

• Two large phase 3 trials (ORCA-2 and ORCA-3) showed an odds ratio of 5.5 for quitting, more than double the nearest competitor.

• Side effect profile is benign, with few adverse events, differentiating it from previous drugs.

• No direct head-to-head trial with Chantix, but confidence in superior efficacy and safety.

• Vaping indication is the next target, with a phase 3 trial planned.

Safety and regulatory milestones

• 300 patients have reached six months of exposure with no major safety issues; 12-month data for 100 patients expected in Q2, to be added post-NDA.

• NDA acceptance expected 60-74 days after submission; PDUFA and potential launch anticipated in Q3-Q4 2026.