Achieve Life Sciences to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call and Webcast on March 24, 2026
MWN-AI** Summary
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company, has announced its plans to release financial results for the fourth quarter and full year of 2025 on March 24, 2026, at 8:30 AM EDT. Alongside these results, the company will provide updates on its development program for cytisinicline, a treatment aimed at nicotine dependence.
Cytisinicline is a plant-based alkaloid that targets the nicotinic acetylcholine receptor in the brain, helping to mitigate the symptoms of nicotine cravings and reduce the satisfaction derived from nicotine consumption. This product is particularly relevant given the alarming statistics surrounding tobacco use, which is a leading cause of preventable death globally, with millions suffering from smoking-related health issues. While Achieve Life Sciences has made significant progress, including the acceptance of its New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA)—with a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026—cytisinicline is still classified as an investigational product.
The upcoming earnings report will likely offer insights into Achieve’s ongoing clinical trials. Recently, they completed a Phase 2 study for vaping cessation, emphasizing the growing urgency to address nicotine addiction in the wake of rising e-cigarette usage, particularly among students. The lack of FDA-approved treatments for e-cigarette cessation underlines the critical need for effective solutions, and cytisinicline could be positioned to fill this gap.
Investors and stakeholders can listen to the call by dialing into the conference or through a live webcast. A replay will also be available post-call, reflecting the company's commitment to transparency in its financial and developmental progress.
MWN-AI** Analysis
Achieve Life Sciences, Inc. (Nasdaq: ACHV) is scheduled to announce its fourth quarter and full-year 2025 financial results on March 24, 2026. Investors should closely monitor this event as it comes at a pivotal moment for the company, which is focusing on the commercialization of cytisinicline for smoking and vaping cessation.
The FDA's acceptance of Achieve's New Drug Application (NDA) in September 2025 adds significant potential for market success, especially given the PDUFA date of June 20, 2026. Investors should consider that cytisinicline addresses a substantial market demand, with approximately 25 million adults in the U.S. still smoking combustible cigarettes, and the growing concern over vaping, which affects nearly 18 million adults. The recent increase in youth vaping only amplifies the urgency for effective cessation products, which presents Achieve with unique market positioning.
As the company transitions from clinical development to commercialization, analysts should pay attention to the results of the Phase 3 studies and the outcomes from the Phase 2 study regarding vaping cessation. Positive results can lead to heightened investor confidence and a rise in stock price, as well as potential partnerships or acquisitions by larger pharmaceutical firms.
That said, it’s crucial to approach with caution, given the inherent risks and uncertainties highlighted in Achieve's disclosures. Regulatory timelines can be unpredictable, and market conditions can change rapidly. Investors are advised to keep a close eye on the March 24 conference call for insights about the financial performance and strategic vision of Achieve post-approval. Furthermore, adhering to market trends and public health policies related to tobacco use will be essential for long-term performance. Careful analysis of the upcoming earnings call can provide valuable indicators for future stock movements.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SEATTLE and VANCOUVER, British Columbia, March 17, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced it will report its fourth quarter and full year 2025 financial results and provide a corporate update on the cytisinicline development program on Tuesday, March 24, 2026, at 8:30 AM EDT.
To access the webcast, please use the following link: 4Q25 Earnings Webcast. Alternatively, you may access the live conference call by dialing 877-269-7756 (U.S. & Canada) or 201-689-7817 (International) and referencing conference ID 13758715. A webcast replay will be available approximately three hours after the call and archived on the website for 90 days.
About Achieve Life Sciences, Inc.
Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence. In September 2025, the company announced that its New Drug Application, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026. The NDA is for cytisinicline to be used as a treatment of nicotine dependence for smoking cessation in adults, based on two successfully completed Phase 3 studies and its open-label safety study. Additionally, the company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.
About Cytisinicline
There are approximately 25 million adults in the United States who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3
In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.4 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded the Commissioner’s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need.
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the FDA for any indication in the United States.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements Achieve makes regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
Achieve Contact
Nicole Jones
VP, Strategic Communications and Stakeholder Relations
ir@achievelifesciences.com
425-686-1510
References
1National Center for Health Statistics. National Health Interview Survey, 2023 and 2024. 2026 (https://www.cdc.gov/nchs/nhis.htm).
2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
4Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924.
FAQ**
How does Achieve Life Sciences Inc. (Nasdaq: ACHV) plan to leverage the acceptance of its New Drug Application for cytisinicline to expand its market presence in Seattle and Vancouver?
Given the population's health concerns, what strategies will Achieve Life Sciences Inc. (ACHV) implement in Seattle and Vancouver to promote the use of cytisinicline for nicotine dependence?
How does Achieve Life Sciences Inc. (ACHV) expect regulatory feedback from the FDA to impact its business operations in the Seattle and Vancouver markets post-PDUFA date of June 20, 2026?
What role does Achieve Life Sciences Inc. (ACHV) envision for cytisinicline in addressing vaping-related nicotine dependence among the youth in Seattle and Vancouver after its upcoming earnings report?
**MWN-AI FAQ is based on asking OpenAI questions about Achieve Life Sciences Inc. (NASDAQ: ACHV).
NASDAQ: ACHV
ACHV Trading
4.47% G/L:
$5.37 Last:
453,265 Volume:
$5.35 Open:
