Shares of Achieve Life Sciences Inc. (ACHV, -1.09%) 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 (FDA), the agency expressed the need for longer-term data beyond 12 weeks to assess potential safety risks of cytisinicline. The FDA views smoking cessation drugs as products for chronic, intermittent use, as mentioned in Achieve Life Sciences’ regulatory filing on Monday.
This latest development suggests delays in Achieve’s filing of a new drug application for the treatment. Initially expected in the first half of 2024, Oppenheimer analysts noted in a Monday note and revised their price target of Achieve shares from $21 to $18, owing to the resulting uncertainty and anticipated delays in the product’s launch.
Despite these setbacks, cytisinicline has demonstrated a favorable safety record thus far and is deemed as “well-positioned for commercial success” by the analysts. This is particularly significant considering that there are approximately 34 million cigarette smokers in the U.S.
As of now, Achieve Life Sciences shares have gained over 120% this year, whereas the S&P 500 has shown a 20% increase.
While Achieve Life Sciences Inc. faces obstacles with the delayed launch of its smoking cessation treatment, cytisinicline, the company remains optimistic about its successful commercialization. With a large target market and a favorable safety record, Achieve’s efforts to combat smoking addiction continue to show promise.