Analyst Justin Walsh from JonesTrading reiterated a Buy rating on Achieve Life Sciences and keeping the price target at $20.00.
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Justin Walsh has given his Buy rating due to a combination of factors including the recent FDA acceptance of Achieve Life Sciences’ NDA for cytisinicline, which is aimed at smoking cessation. This acceptance marks a significant step forward, with a PDUFA date set for June 20, 2026, indicating a potential market entry in the second half of 2026. The NDA is backed by robust clinical data from two Phase III trials and an open-label study, suggesting a strong likelihood of approval.
Moreover, cytisinicline could become the first FDA-approved nicotine addiction treatment in two decades, presenting a unique market opportunity. Walsh estimates substantial revenue potential, with risk-adjusted projections of $680 million in the U.S. and $180 million in the E.U. and U.K. by FY33. The strategic partnership with Omnicom Group to emphasize smoking as a medical condition and target high-prescribing physicians further strengthens the commercial outlook for cytisinicline.
In another report released today, Lake Street also reiterated a Buy rating on the stock with a $11.00 price target.