: Achieve Life Sciences shares drop as analysts see delayed launch of smoking-cessation treatment

Achieve Life Sciences Inc. shares ACHV dropped 25% premarket on Tuesday as analysts forecasted delays in the launch of the company’s smoking cessation treatment cytisinicline. In a recent meeting with the U.S. Food and Drug Administration, the agency said it would need longer-term data beyond 12 weeks to assess potential safety risks of cytisinicline, given that the regulator views smoking cessation drugs as products for chronic, intermittent use, Achieve Life Sciences said in a regulatory filing Monday. The FDA’s questions suggest delays in Achieve’s filing of a new drug application for the treatment, which was originally expected in the first half of 2024, Oppenheimer analysts said in a note Monday. The resulting uncertainty and anticipated delays in the product’s launch prompted the analysts to cut their price target on Achieve shares to $18, from $21 previously. Even so, cytisinicline has a favorable safety record so far and is “well-positioned for commercial success,” the analysts said, with about 34 million cigarette smokers in the U.S. Achieve Life Sciences shares have gained more than 120% in the year to date, while the S&P 500 is up 20%.

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