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

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We came across a bullish thesis on Achieve Life Sciences, Inc. on DF Research’s Substack by Keith Dalrymple. In this article, we will summarize the bulls’ thesis on ACHV. Achieve Life Sciences, Inc.’s share was trading at $3.1500 as of October 3rd.

Achieve Life Sciences (ACHV) is entering a critical phase with the submission of its new drug application (NDA) for Cytisinicline to the FDA in June, marking a pivotal milestone in its journey to bring the first new smoking cessation product in 20 years to market. With an estimated 29 million smokers in the U.S. and a growing population of alternative nicotine users, Cytisinicline’s strong efficacy and safety profile positions it as a potentially high-impact therapy. The NDA submission initiates the countdown to an FDA approval decision expected in late 2Q26, with the acceptance letter anticipated imminently.

This milestone, combined with the company’s two-pronged strategy—pursuing a potential partnership or sale to Big Pharma while developing a drug launch strategy with Omnicom—creates multiple pathways to unlock shareholder value. ACHV is positioned for either a buy-out at $8-16 per share or, if no offer meets management’s valuation, a commercial launch by late 2026, with Omnicom providing marketing and sales support. The company recently raised $45 million in a dilutive financing, which temporarily pressured the stock but leaves ACHV adequately funded through mid-2026.

Cytisinicline’s market opportunity, based on the historical performance of Chantix and growing nicotine dependence treatments, suggests revenues of $260-$500 million, implying a potential enterprise value of $750 million to $1.3 billion under a 3x sales multiple. With the product approval decision likely within a year and a well-de-risked pipeline, ACHV offers investors a high-risk, high-reward opportunity, either through an imminent buy-out or through the successful launch of a novel therapy in a large, under-addressed market.

Previously we covered a bullish thesis on Achieve Life Sciences, Inc. (ACHV) by Rogue Funds in March 2025, which highlighted Cytisinicline’s strong efficacy, long-term safety data completion, and potential priority FDA review. The company’s stock price appreciated approximately by 18% since our coverage, as the thesis played out with continued regulatory progress. Keith Dalrymple shares a similar perspective but emphasizes the buy-out versus launch strategy and potential $8-16 per share valuation.

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Disclosure: None.