SEATTLE and VANCOUVER, British Columbia - Achieve Life Sciences, Inc. (NASDAQ:ACHV), a pharmaceutical company in late-stage development of cytisinicline for smoking cessation and currently valued at $122 million, announced today that its ORCA-OL clinical trial has met a significant milestone. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.78x, indicating robust short-term financial stability. The trial has documented that over 300 participants have completed six months of treatment with cytisinicline, fulfilling the long-term exposure requirement set by the U.S. Food and Drug Administration (FDA) for a New Drug Application (NDA) submission.
The FDA had previously requested six-month safety data for cytisinicline to be included in Achieve's planned NDA, which is slated for submission in the second quarter of 2025. The ongoing Data Safety Monitoring Committee (DSMC) review has not identified any safety concerns, enabling the study to continue without modifications.
Cindy Jacobs, Ph.D., M.D., President and Chief Medical (TASE:PMCN) Officer of Achieve, expressed gratitude to the clinical sites and participants for their commitment, highlighting the potential impact of cytisinicline on public health. Rick Stewart, CEO of Achieve, emphasized the importance of this development, noting that it brings the company closer to potentially introducing the first new FDA-approved smoking cessation treatment in nearly two decades. Analysts share this optimism, with InvestingPro data showing price targets ranging from $10 to $30 per share, significantly above current trading levels. However, investors should note that the company is currently burning through cash rapidly, one of several key insights available in the comprehensive Pro Research Report covering this and 1,400+ other US stocks.
The ORCA-OL trial is an open-label study designed to evaluate the long-term safety of a 3 mg cytisinicline dosing regimen administered three times daily. The trial is conducted across 29 U.S. clinical sites and aims to provide the FDA with required safety data from at least 300 participants treated over a cumulative six-month period, with additional data on subjects treated for a cumulative one-year period to be submitted before potential product approval.
Achieve has already completed two Phase 3 clinical trials of cytisinicline, encompassing over 1,600 subjects who are seeking to quit smoking or vaping. The company is also planning to initiate a single Phase 3 clinical study in vaping cessation later in 2025.
This progress is based on a press release statement from Achieve Life Sciences and is a critical step toward the potential commercialization of cytisinicline, which has been granted Breakthrough Therapy designation for nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid that targets nicotinic acetylcholine receptors to potentially help individuals overcome nicotine addiction. While the company maintains more cash than debt on its balance sheet, InvestingPro analysis indicates that profitability remains a key challenge, with analysts not anticipating positive earnings this year. The stock currently trades near its 52-week low, and investors seeking deeper insights can access over 30 additional financial metrics and analysis through InvestingPro's comprehensive research tools. However, it is important to note that cytisinicline is still an investigational product and has not yet been approved by the FDA.
In other recent news, Achieve Life Sciences has made significant strides in nicotine addiction treatment, with a strategic shift from clinical development to a commercial approach for its smoking cessation drug, cytisinicline. The company anticipates a New Drug Application (NDA) for cytisinicline in Q2 2025, potentially marking the first new prescription smoking cessation aid in nearly two decades. Furthermore, plans for a Phase 3 trial for vaping cessation in Q3 2025 have been disclosed.
Financially, Achieve Life Sciences reported a net loss of $12.5 million for Q3 2024 but managed to refinance $20 million in debt. In addition, the company recently announced the appointment of Mark K. Oki as the new Chief Financial Officer. Mr. Oki brings extensive experience from his previous roles in the pharmaceutical and life sciences sectors, and his employment agreement includes an initial annual base salary of $450,000 and potential for an annual discretionary bonus.
On the analyst front, Rodman & Renshaw recently initiated coverage on Achieve Life Sciences with a Buy rating, emphasizing the company's commitment to addressing the global health crisis of nicotine addiction. However, it's worth noting that four analysts have recently revised their earnings expectations downward for the upcoming period. These are the recent developments for Achieve Life Sciences, indicating a promising outlook for its endeavors in nicotine addiction treatment.
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