Achieve Life Sciences Inc. (NASDAQ:ACHV) is moving closer to a pivotal moment as it seeks FDA approval for cytisinicline, a potential first new smoking cessation therapy in nearly two decades, positioning the company for a high-stakes commercial launch in 2026.
In a vote of confidence for the late-stage specialty pharmaceutical company’s pipeline with a focus on smoking health and nicotine dependence, HC Wainwright has initiated coverage on Achieve Life Sciences with a Buy rating and a $12 price forecast.
In June, Achieve Life Sciences submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline for nicotine dependence for smoking cessation in adults.
The cytisinicline NDA is supported by a combination of efficacy and well-tolerated safety results from two Phase 3 trials, ORCA-2 and ORCA-3, which evaluated cytisinicline for smoking cessation.
In both studies, cytisinicline administered for 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater abstinence rates by the end of treatment and long-term abstinence through week 24 compared to placebo.
The company has also included safety data on over 300 participants with at least six months of cumulative cytisinicline exposure.
In June, the company raised around $45 million to fund continued advancement of cytisinicline through potential FDA marketing approval of cytisinicline and for working capital and general corporate purposes.
The company expects the funding to provide runway into the second half of 2026.
Analyst Brandon Folkes says, “With the New Drug Application (NDA) now submitted, and a potential FDA approval and commercial launch in 2026, we view the next 12 to 18 months as a period of potential significant value inflection for ACHV stock.”
Achieve Life Sciences’ shares undervalue the commercial potential of cytisinicline, given the shortcomings of current therapies, rising smoking and vaping rates, and its superior efficacy and tolerability versus Pfizer Inc.’s (NYSE:PFE) Chantix (varenicline) and generics.
Folkes sees tolerability as a key edge for cytisinicline, noting varenicline’s side effects have limited its use. He argues that Achieve Life Sciences’ valuation fails to capture the strong NDA data or the sizable market opportunity, where peak sales could far exceed the company’s current worth.
According to an investor note from Folkes, a rational pricing strategy for cytisinicline, potentially ranging from $500 to $3,000 per month, could be justified by the significant health economic costs associated with smoking.
Cytisinicline could become the first FDA-approved smoking cessation therapy in nearly 20 years, with a U.S. launch expected in 2026.
Its differentiated profile, flexible dosing, and broad adoption potential position it well in a $13 billion global market. Before its withdrawal, Pfizer’s Chantix generated nearly $1 billion annually in U.S. sales, highlighting the sizable opportunity relative to Achieve’s current valuation.
Price Action: ACHV stock is trading higher by 14.92% to $2.97 at last check Thursday.
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