Achieve Life Sciences to Present at the Jefferies Global Healthcare Conference
MWN-AI** Summary
Achieve Life Sciences, Inc. (NASDAQ: ACHV), a Seattle and Vancouver-based late-stage specialty pharmaceutical company, is set to present at the Jefferies Global Healthcare Conference from June 3-5, 2025, in New York City. Rick Stewart, the company's CEO, will deliver the presentation on June 4 at 5:30 PM EDT, with a live webcast available on their Investor Relations website.
The company's primary focus is on the development and commercialization of cytisinicline, a promising treatment for nicotine dependence aimed at smoking cessation. Achieve Life Sciences has successfully completed two Phase 3 trials for cytisinicline and is progressing through the final stages of a Phase 2 study focusing on vaping cessation. With an ongoing open-label safety study fully enrolled, the company is preparing to submit a new drug application for smoking cessation by June 2025. Notably, the FDA has granted Breakthrough Therapy designation for cytisinicline, recognizing the critical need for effective e-cigarette cessation aids.
Cytisinicline is a plant-derived alkaloid that binds to nicotinic acetylcholine receptors in the brain. It is designed to mitigate nicotine cravings and diminish the satisfaction derived from nicotine use, making it a unique contender in the fight against nicotine addiction. This drug is particularly relevant given the alarming statistics about tobacco-related deaths and the increasing prevalence of vaping among adolescents.
Despite optimistic developments, Achieve Life Sciences acknowledges the inherent risks associated with drug development, including potential regulatory hurdles and market dynamics. Stakeholders and investors are encouraged to monitor the company's upcoming presentations and developments closely as they navigate these challenges. For more detailed information, Achieve Life Sciences can be reached through their Investor Relations contact.
MWN-AI** Analysis
Achieve Life Sciences, Inc. (NASDAQ: ACHV) has garnered investor attention as it prepares to present at the Jefferies Global Healthcare Conference on June 4, 2025. The focus will be on cytisinicline, an investigational treatment for nicotine dependence. Given the pressing global health crisis related to smoking and vaping, the conference presentation presents a pivotal opportunity for Achieve to enhance visibility and potentially attract new investments.
The company's recent advances, including the successful completion of two Phase 3 trials for smoking cessation and progressing towards a new drug application (NDA) submission, underscore its commitment to commercializing cytisinicline. The FDA's Breakthrough Therapy designation indicates recognition of cytisinicline's potential to fill a significant gap in treatment options for nicotine addiction, particularly in the e-cigarette market, where no approved therapies currently exist.
From a market standpoint, investors should carefully monitor the outcomes of the NDA submission and subsequent regulatory feedback. Any delays or opposition from the FDA could impact stock performance. The current smoking population in the U.S., alongside the alarming rise in vaping among youths, offers a substantial market opportunity; however, investors must consider the inherent risks detailed in Achieve's communications, including financing needs, competitive landscape shifts, and future regulatory hurdles.
In summary, while Achieve Life Sciences presents a compelling case for growth in addressing global nicotine dependencies, potential investors should weigh both the opportunities presented by cytisinicline's promising clinical data and the operational risks involved in bringing such an innovative product to market. Monitoring the developments from the Jefferies Conference and the FDA process will be key for gauging the stock's trajectory in the near term.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SEATTLE and VANCOUVER, British Columbia, May 28, 2025 (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 for smoking cessation, today announced that the company will present at the Jefferies Global Healthcare Conference being held June 3–5, 2025, in New York City.
Rick Stewart, Chief Executive Officer of Achieve, will present on Wednesday, June 4, 2025, at 5:30 PM EDT. A live webcast and replay of the presentation will be available on the Investor section of the company’s website. For more information, please contact your banking representative directly or visit the Achieve Life Sciences Investor Relations website .
About Achieve Life Sciences, Inc.
Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in June 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.
About Cytisinicline
There are approximately 29 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 over 11 million adults in the United States who use e-cigarettes, also known as vaping. 4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes. 5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA 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 for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration 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 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, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, 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.
Achieve Contact
Nicole Jones
ir@achievelifesciences.com
425-686-1510
References
1 VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
2 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
3 U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
4 Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
5 Jamal 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 might the presentation of Achieve Life Sciences Inc. (ACHV) at the Jefferies Global Healthcare Conference impact investor interest in its cytisinicline development for smoking cessation in Seattle and Vancouver?
What potential market opportunities does Achieve Life Sciences Inc. (ACHV) see in Seattle and Vancouver for its cytisinicline treatment, given the high rates of nicotine dependence?
How do regulatory environments in Seattle and Vancouver affect Achieve Life Sciences Inc. (ACHV) plans for launching cytisinicline after FDA approval?
What partnerships or collaborations might Achieve Life Sciences Inc. (ACHV) pursue in Seattle and Vancouver to enhance the commercialization of cytisinicline for smoking cessation?
**MWN-AI FAQ is based on asking OpenAI questions about Achieve Life Sciences Inc. (NASDAQ: ACHV).
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