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alternative to legacy smoking cessation drugs such as Pfizer’s Chantix and GlaxoSmithKline’s Zyban, both of which were withdrawn from the U.S. market and carried higher side-effect burdens.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.

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Disclosure: None.