H.C. Wainwright analyst Brandon Folkes has reiterated their bullish stance on ACHV stock, giving a Buy rating on November 3.
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Brandon Folkes’s rating is based on several key developments that bolster the outlook for Achieve Life Sciences. The acceptance of the New Drug Application (NDA) for cytisinicline by the FDA marks a significant milestone, setting a timeline for a potential U.S. launch in the latter half of 2026. Additionally, the unexpected award of a Commissioner’s National Priority Voucher (CNPV) for vaping cessation accelerates the review process, potentially bringing the product to market within the next 18 to 24 months. These regulatory advancements are seen as underappreciated in the current stock price, supporting the Buy rating.
Moreover, the publication of new data in Thorax highlights cytisinicline’s efficacy in improving smoking quit rates among adults with chronic obstructive pulmonary disease (COPD), further differentiating it as a treatment option. The Phase 3 trials, ORCA-2 and ORCA-3, have demonstrated statistically significant improvements in smoking abstinence, backed by a robust safety profile. These factors position cytisinicline as a leading candidate for FDA approval in the smoking and vaping cessation markets, making Achieve Life Sciences an attractive asset for large pharmaceutical companies considering entry or re-entry into this space.
In another report released on November 3, Lake Street also reiterated a Buy rating on the stock with a $11.00 price target.