Achieve Life Sciences, Inc. (ACHV): A Bull Case Theory

We came across a bullish thesis on Achieve Life Sciences, Inc. on Hunterbrook’s Substack. In this article, we will summarize the bulls’ thesis on ACHV. Achieve Life Sciences, Inc.'s share was trading at $4.18 as of January 30th.

Achieve Life Sciences, Inc., a late-stage pharmaceutical company, develops and commercializes cytisinicline for nicotine independence in Canada, the United States, and the United Kingdom. ACHV is approaching a pivotal inflection point as it awaits FDA approval for cytisinicline, a plant-derived, non-nicotine therapy designed to treat smoking addiction, with a regulatory decision expected by June 20, 2026. ACHV is a roughly $250 million company positioning cytisinicline as a potentially best-in-class alternative to legacy smoking cessation drugs such as Pfizer’s Chantix and GlaxoSmithKline’s Zyban, both of which were withdrawn from the U.S. market and carried higher side-effect burdens.

Cytisinicline has already been used safely for decades in Europe and has demonstrated strong efficacy and tolerability in the U.S., supported by two successful Phase 3 trials and a long-term safety study showing no treatment-related serious adverse events. Under the Affordable Care Act, FDA-approved smoking cessation therapies are broadly reimbursed, creating a favorable commercial backdrop if approval is granted. Smoking remains a massive unmet medical need, with roughly 29 million U.S. smokers, over half attempting to quit each year but fewer than 10% succeeding, underscoring the demand for more effective therapies.

Beyond smoking cessation, ACHV is also pursuing approval for vaping cessation, where no FDA-approved therapies currently exist, and cytisinicline has received Breakthrough Therapy designation following positive Phase 2 data. Financially, ACHV ended Q3 2025 with $48 million in cash, providing runway through the FDA decision, though additional capital will likely be required for commercialization. If approved, cytisinicline could unlock a large, reimbursed market with limited competition, positioning ACHV for a significant re-rating as it transitions from a development-stage biotech to a commercial-stage company with meaningful revenue potential.

Previously, we covered a bullish thesis on Achieve Life Sciences, Inc. (ACHV) by Rogue Funds in March 2025, which highlighted the regulatory de-risking of cytisinicline, strong Phase 3 efficacy, and valuation upside tied to NDA progress. ACHV’s stock price has appreciated by approximately 56.55% since our coverage due to advancing FDA milestones and improving approval visibility. Hunterbrook shares a similar thesis but emphasizes commercialization potential and the opportunity in vaping cessation.

Achieve Life Sciences, Inc. is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 12 hedge fund portfolios held ACHV at the end of the third quarter which was 15 in the previous quarter. While we acknowledge the potential of ACHV as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

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Disclosure: None.