Shares of micro-cap Achieve Life Sciences rose 5% on Tuesday, January 7, following the company’s announcement that its clinical trial for a smoking cessation drug successfully reached a critical milestone. This progress allows Achieve to file for regulatory approval and, if granted, begin commercial sales.
Details
On January 7, Achieve’s stock price on Nasdaq increased 5% to $3.70 per share. Over the last 12 months, the stock has seen a modest decline of nearly 4%.
The company announced that its clinical trial had achieved its goal, specifically addressing the long-term use of its smoking cessation drug, cytisinicline. The trial was conducted to satisfy a requirement by the U.S. FDA, which had previously declined to consider the drug for approval without such data. The FDA argued that smokers could experience relapses and might require multiple treatment courses.
The latest trial results demonstrated that prolonged use of the drug is safe, the company stated. With the FDA’s requirement now met, Achieve plans to submit its approval application in the second quarter of 2025.
About Achieve Life Sciences
Achieve Life Sciences has a 30-year history but took its current form in 2017 following several mergers. The company is developing a treatment for nicotine and vaping addiction based on cytisinicline, a plant-derived alkaloid.
In July 2024, the FDA granted the drug “breakthrough therapy” designation for treating vaping addiction, as there are no similar treatments currently available. This designation could accelerate its entry onto the market, allowing it to bypass phase III trials.
If approved, cytisinicline could significantly impact global public health, according to analysts at Freedom Finance Global. The World Health Organization reports that the “tobacco epidemic” claims over 8 million lives annually: 7.0 million from direct use and 1.3 million from secondhand smoke exposure.
Analyst insights
In November, Zacks Small-Cap Research (Zacks SCR) released a report setting a price target for Achieve shares at $30 per share, eight times the most recent closing price. The analysts highlighted significant changes in the company’s business in recent months, including the “breakthrough therapy” designation for cytisinicline, accelerated progress in other studies, and a revamped leadership team. They noted that Achieve is now leaning toward independently commercializing its drugs after approval rather than selling them to a strategic partner.
Achieve currently has eight “buy” recommendations from analysts and no “sell” ratings, according to MarketWatch. The average target price is $15.56 per share, suggesting over 400% upside versus the last close.
