Achieve Life Sciences Inc experienced a significant drop in its shares on Tuesday following analysts’ predictions of potential delays in the launch of the company’s smoking cessation treatment, cytisinicline, after a recent meeting with the US Food and Drug Administration (FDA). The stock, which had concluded Monday’s trading at $5.45, saw a stark opening at $3.89 and continues its decline.
At the time of this publication, Achieve Life Sciences Inc stock (ACHV) has witnessed a decline.
Achieve Life Sciences Inc
Current Price: $3.08
Change : -2.37
Change (%): (-43.49%)
Volume: 811.2K
Source: Tomorrow Events Market Data
During a recent meeting with the FDA, Achieve Life Sciences disclosed that the regulatory agency indicated a requirement for longer-term data, extending beyond the standard 12 weeks, to assess potential safety risks associated with cytisinicline. The FDA, deeming smoking cessation drugs as products for chronic, intermittent use, expressed the need for additional information. This revelation, as outlined in a regulatory filing on Monday, suggests potential setbacks in Achieve’s submission of a new drug application for cytisinicline, initially anticipated in the first half of 2024, according to analysts from Oppenheimer.
In light of the FDA’s inquiries and the subsequent uncertainty surrounding the product’s launch, Oppenheimer analysts decided to revise their price target on Achieve shares. Previously set at $21, the new target is now $18, reflecting a cautious outlook. MorningStar reported that the adjustment is a response to the anticipated delays in the drug’s market debut.
Despite the challenges, analysts remain optimistic about cytisinicline’s potential success in the market. The treatment boasts a favorable safety record thus far and is deemed “well-positioned for commercial success” by Oppenheimer analysts. With approximately 34 million cigarette smokers in the United States, there is a substantial market for smoking cessation products.
The recent performance of Achieve Life Sciences stock reflects the market’s reaction to these developments. Over the last five days, the stock has experienced a significant decline of 42.67%, while the one-month and three-month performances indicate drops of 30.06% and 35.24%, respectively. Despite these setbacks, Achieve Life Sciences has seen a year-to-date increase of 28.46%, and over the past year, the stock has shown a growth of 21.05%. These fluctuations underscore the challenges and uncertainties the company faces as it navigates the regulatory landscape and works towards the launch of cytisinicline. Investors will be closely monitoring further developments and regulatory updates as Achieve Life Sciences addresses concerns raised by the FDA and seeks to advance its smoking cessation treatment to market.
