Achieve Life Sciences posts corporate deck on cytisinicline nicotine dependence treatment launch plan

• Achieve Life Sciences outlined a regulatory path for cytisinicline for smoking cessation, with a PDUFA date of June 20, 2026.
• U.S. launch expected in 1H 2027, positioning cytisinicline as a potential first new FDA-approved nicotine-dependence treatment in 20 years.
• Phase 3 ORCA trials showed higher quit rates versus placebo, including 25.3% vs 4.4% on a 6-week regimen and 32.6% vs 7% on a 12-week regimen at primary endpoints.
• Company highlighted a vaping cessation program supported by Phase 2 ORCA-V1 results showing 2.6x higher likelihood of quitting versus placebo (p=0.035), with Breakthrough Therapy designation and a Commissioner's National Priority Voucher cited as potential review accelerants.
• Management framed commercial opportunity around up to 50 million Americans who use tobacco, citing about $11 billion estimated prescription-market opportunity for smoking cessation.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Achieve Life Sciences Inc. published the original content used to generate this news brief on May 03, 2026, and is solely responsible for the information contained therein.