Achieve Life Sciences \[ACHV\] has developed the first drug to treat nicotine dependence in a generation, and results of their Phase 3 trials indicate a major competitive advantage over existing options. They are also the first company to run clinical trials for vaping cessation, with initial results showing promise as well.
There are currently around 49.2 million nicotine-addicted adults in the United States alone. Roughly half of these individuals make at least one attempt to quit each year. Nearly half of the attempted quitters try using an additional therapeutic for assistance. A single treatment course may cost around $500, so if this drug can catch even 20% of the market share, annual revenue will exceed $1 billion. Given that the FDA just rolled back restrictions on flavored vape products, we can expect another generation of vape-addicted children to drive demand for many years to come!
Cytisinicline Is a drug developed from the natural product cytisine, which has been sold as an OTC supplement in Europe for decades. There are many Reddit posts describing cytisine’s effectiveness for assisting with smoking cessation, and I have yet to find significant negative feedback. The consensus aligns with results from clinical trials showing superior efficacy over existing treatment options while offering a much more mild side effect profile than varenicline or bupropion. Cytisinicline outperformed existing treatments in head-to-head trials and in groups who had failed to quit using other interventions. I have searched extensively for indications of toxicity in case reports, and in one case report, cytisine failed to cause organ damage even after two suicide attempts with up to 90 tablets ingested. It would be very surprising to see toxicity issues come up at this stage, as safety is also weighed against the risk of continued smoking.
The FDA has designated this as a breakthrough therapy with a national priority voucher to avoid delays in application review. The due date for the initial decision is June 20, but an issue with their previous 3rd party manufacturer required the company to source a new one, resulting in potential delay in their approval timeline. While the company has already completed a technology transfer and validation batches with a new manufacturer, they expect to receive a CRL which will delay launch by about 6 months. Achieve Life Sciences has a stack of directors experienced in launching biotech startups and they recently secured $354 million in private financing, providing enough runway to reach production even with the anticipated delay. Their patent for cytisinicline extends to 2040, and I am not aware of any other smoking cessation drugs under development (though GLP-1s are being evaluated as a “catch-all” for addiction treatment).
ACHV is currently trading at $5.50 with a 12-month price target average of $13.63 and high estimate of $21. There may be a temporary drop in price this week if a CRL creates any additional setbacks. If the news is better than expected, this might be the last time we see the price this low.