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SEATTLE/VANCOUVER - Achieve Life Sciences, Inc. (NASDAQ:ACHV), a $120.7 million market cap pharmaceutical company whose stock has shown strong momentum with a 21% gain over the past week, announced Thursday a proposed underwritten public offering of common stock and accompanying warrants to purchase common stock, according to a press release statement. According to InvestingPro analysis, the company currently appears fairly valued based on its Fair Value model.
The late-stage pharmaceutical company, which focuses on developing cytisinicline for smoking cessation, intends to grant underwriters a 30-day option to purchase up to an additional 15% of the securities offered. Citizens Capital Markets and Raymond James are serving as joint book-running managers for the offering. InvestingPro data shows the company maintains a healthy liquidity position with a current ratio of 3.51, indicating strong ability to meet short-term obligations.
Achieve plans to use the proceeds to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital and general corporate purposes. The company submitted its New Drug Application to the FDA earlier this month for cytisinicline as a treatment for nicotine dependence in adults. With analysts maintaining a strong buy consensus and setting price targets significantly above current levels, investors can access detailed analysis and 12 additional key insights through InvestingPro’s comprehensive research report.
The offering is being made pursuant to a previously filed and effective registration statement, with a preliminary prospectus supplement and accompanying prospectus to be filed with the SEC.
Cytisinicline is a plant-based alkaloid that binds to nicotine receptors in the brain. The FDA has granted it Breakthrough Therapy designation for e-cigarette cessation, though it remains an investigational product not yet approved for any indication in the United States.
The company noted that the offering is subject to market conditions, with no assurance regarding its completion or final terms.
Achieve Life Sciences completed two Phase 3 studies and a fully enrolled open-label safety study that supported its recent FDA application. The company has also completed a Phase 2 study for vaping cessation.
In other recent news, Achieve Life Sciences, Inc. announced promising results from its Phase 3 clinical trial, ORCA-3, for the drug cytisinicline, which aims to aid smoking cessation. The trial, involving 792 adult smokers in the United States, demonstrated that cytisinicline significantly reduces nicotine cravings and increases the likelihood of quitting smoking compared to a placebo. Participants received 3mg doses three times daily for either 6 or 12 weeks, with monitoring continuing for 24 weeks. The primary endpoint was achieving continuous abstinence from smoking during the last four weeks of treatment, with additional assessments for continued abstinence up to six months. The study, published in JAMA Internal Medicine, highlighted the drug’s favorable tolerability and limited side effects. Achieve Life Sciences plans to submit a New Drug Application to the FDA in June 2025. Cytisinicline has been granted Breakthrough Therapy designation by the FDA, highlighting its potential to address the lack of approved treatments for nicotine e-cigarette cessation. The company has completed two Phase 3 studies for smoking cessation and one Phase 2 study for vaping cessation, with an ongoing open-label safety study.
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