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On Thursday, Rodman & Renshaw initiated coverage on Achieve Life Sciences (NASDAQ: NASDAQ:ACHV) with a Buy rating and a price target of $12.00. The firm highlighted the company's commitment to combating the global smoking and nicotine addiction crisis through the development and potential commercialization of cytisinicline.
Achieve Life Sciences has set its sights on addressing tobacco use, which is the leading cause of preventable death worldwide, resulting in over 8 million deaths annually. The company's focus is on the significant health impacts of smoking, including lung cancer, pulmonary disease, and coronary heart disease.
With an NDA submission for cytisinicline anticipated in the second quarter of 2025, Achieve is moving forward with its strategy to introduce this potential treatment to the U.S. market.
In addition to seeking approval for cytisinicline, Achieve Life Sciences is exploring further indications for the drug, including its use for e-cigarette and vaping cessation. The company aims to fill the gap in FDA-approved treatments for e-cigarette cessation, which could significantly benefit the more than 11 million adult e-cigarette users in the U.S., especially given the increasing number of young individuals using these products.
As Achieve Life Sciences progresses toward the NDA submission and works towards gaining approval, the firm believes that the value of ACHV shares will become increasingly evident to investors. The anticipation is that within the next 12 to 18 months, the potential impact of cytisinicline on nicotine addiction treatment will be more fully recognized, reflecting positively on the company's market valuation.
In other recent news, Achieve Life Sciences reported on its Q3 progress, announcing a strategic shift from clinical development to a commercial approach with cytisinicline.
Cytisinicline, which has been granted FDA breakthrough therapy designation, could be the first new prescription smoking cessation aid in nearly two decades. Recent developments also include Achieve's $20 million debt refinancing and plans for a Phase 3 trial for vaping cessation in Q3 2025. The firm is also exploring non-dilutive funding options for future studies.
InvestingPro Insights
Recent InvestingPro data provides additional context to Achieve Life Sciences' (NASDAQ: ACHV) current financial position and market performance. The company's market capitalization stands at $155.79 million, reflecting its current valuation in the biotech sector. Despite the positive outlook from Rodman & Renshaw, ACHV's stock has experienced a 9.4% decline over the past week, indicating some short-term volatility.
InvestingPro Tips highlight that Achieve Life Sciences holds more cash than debt on its balance sheet, which could be crucial for funding its ongoing research and development efforts, including the anticipated NDA submission for cytisinicline. However, the company is also quickly burning through cash, a common characteristic of biotech firms in the development stage.
It's worth noting that ACHV is not currently profitable, with a negative P/E ratio of -4.85 for the last twelve months as of Q3 2024. This aligns with the InvestingPro Tip indicating that analysts do not anticipate the company to be profitable this year. This financial situation is typical for biotech companies focused on drug development, where significant investments are made before potential revenue generation.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for ACHV, providing a deeper understanding of the company's financial health and market position as it approaches key milestones in its product development pipeline.
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