We came across a bullish thesis on Achieve Life Sciences, Inc. (ACHV) on Substack by Rogue Funds. In this article, we will summarize the bulls’ thesis on ACHV. Achieve Life Sciences, Inc. (ACHV)’s share was trading at $2.67 as of March 19th.
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Achieve Life Sciences presents a compelling investment opportunity with an exceptional risk-reward profile, particularly following its recent milestone update. The company’s lead drug, Cytisinicline, is a nicotine cessation treatment that has demonstrated superior efficacy and safety compared to Chantix, the previous market leader. Achieve recently announced that over 300 participants have completed six months of treatment in the ORCA-OL trial, fulfilling the long-term exposure requirement for its NDA submission. This significant milestone keeps the company on track for an NDA filing in Q2 2025, with no safety concerns reported. Given Cytisinicline’s breakthrough designation and strong clinical results, the likelihood of a priority review is high, potentially leading to an approval decision by late 2025.
The stock remains near its 52-week low despite substantial de-risking. With long-term safety data now largely addressed, Achieve has cleared one of the final regulatory hurdles, further strengthening its investment case. The FDA has already indicated that the company can proceed with the NDA submission after the six-month study, with the 12-month safety data to be submitted post-approval as a label update. This suggests minimal regulatory risk, positioning Cytisinicline for a potential market launch next year. Moreover, Cytisinicline’s efficacy metrics significantly outperform Chantix, with odds ratios of 5.0-6.3 in 12-week trials compared to Chantix’s 2.88, while also exhibiting fewer side effects.
From a valuation perspective, Achieve remains deeply undervalued. The nicotine cessation market represents a multi-billion-dollar opportunity, with Cytisinicline well-positioned to capture significant market share. Chantix, even as a generic, is priced at approximately $475 per treatment course, whereas Cytisinicline, with its superior profile, could command a premium in the $700-$800 range. Even at a conservative 30% market share, this translates to $300 million in revenue, implying a valuation of $1 billion at just 3x sales. A 60% market share could push revenue to $600 million and valuation to $1.8 billion. Given the company’s current market cap and 55 million diluted shares, the stock could reasonably trade between $15-$30 per share, representing a potential 5x-10x upside.
Adding further conviction to the thesis, Achieve recently appointed new investment banking board members and has secured funding through Q3 2025, signaling potential strategic interest, including a buyout scenario. If Cytisinicline receives priority review, PDUFA could be scheduled for late 2025, catalyzing significant price appreciation. Given its breakthrough designation, compelling efficacy, and safety, biopharma investors may soon recognize the valuation disconnect, driving the stock higher well ahead of NDA approval. With the most significant regulatory risk now mitigated and a clear timeline for commercialization, Achieve Life Sciences represents an asymmetric investment opportunity with substantial upside potential.
Achieve Life Sciences, Inc. (ACHV) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 9 hedge fund portfolios held ACHV at the end of the fourth quarter which was 6 in the previous quarter. While we acknowledge the risk and potential of ACHV as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than ACHV but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock.
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Disclosure: None. This article was originally published at Insider Monkey.