Achieve Life Sciences highlights cytisinicline path to FDA approval, commercial launch in corporate presentation
Reuters2026/09/02 21:14- Achieve Life Sciences investor presentation outlined plans to push smoking-cessation drug cytisinicline toward US approval, with a PDUFA date of Jun 20, 2026.
- Phase 3 pooled data showed continuous abstinence of 31.5% vs 8.2% on placebo at weeks 9-12; odds ratio 5.3.
- At weeks 9-24, pooled continuous abstinence was 20.8% vs 4.5%; odds ratio 5.5.
- Financing package totals up to $354 million, including $180 million upfront and up to $174 million in FDA-approval-triggered warrants.
- Commercial buildout highlighted hires from Verona Pharma’s Ohtuvayre launch team, positioning for a potential US launch in Q4 2026.
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