SEATTLE and VANCOUVER, British Columbia, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (NASDAQ:ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced the appointments of Ronald Dadino as Senior Vice President, Chemistry, Manufacturing and Controls (CMC) and Supply Chain, and Gloria Cosgrove as Senior Vice President, Quality. Both executives bring decades of leadership across pharmaceutical manufacturing, supply chain, and quality. They join Achieve as the Company advances cytisinicline toward resubmission of its New Drug Application (NDA) and anticipated U.S. commercial launch.

The appointments establish new, dedicated senior leadership over Achieve’s manufacturing, supply chain, and quality functions. Holding CMC, supply chain, and quality leadership in house, under executives with deep regulated-manufacturing experience, positions Achieve to manage these systems with rigor and control as it prepares for commercialization.

"Ron and Gloria are precisely the leaders we want building Achieve," said Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. "Between them they have taken complex products through global approval and built the quality systems that made those approvals possible. We rebuilt this part of the organization ahead of resubmission because manufacturing and quality will enable the delivery of a reliable medicine to patients."

Mr. Dadino brings more than four decades of leadership in pharmaceutical chemistry, manufacturing and controls, technical operations, and supply chain. He began his career as a research pharmacist at Merck and went on to spend 13 years at Johnson & Johnson, where he served as Vice President, Development and Technical Operations and led organizations responsible for developing and commercializing complex products, including the global approval of first-in-class products. He has since held senior CMC, manufacturing, and supply chain leadership roles across the specialty pharmaceutical and biotechnology sector. At Achieve, he leads the Company’s CMC and supply chain organization, with responsibility for manufacturing, technical operations, and the end-to-end cytisinicline supply chain, from raw material through finished, packaged product.

"I have spent my career building and transferring manufacturing processes and standing up supply chains that hold up under regulatory scrutiny," said Mr. Dadino. "Achieve has a differentiated medicine and is transitioning its finished product manufacturing to the United States. I look forward to building an operation that delivers cytisinicline reliably and at scale."

Ms. Cosgrove brings more than 30 years of quality leadership across global pharmaceutical and biotechnology organizations. She spent 26 years at Boehringer Ingelheim in Global Quality Assurance before moving into senior quality leadership at Regeneron Pharmaceuticals. She subsequently served as Vice President, Quality at Seres Therapeutics, where she led quality through the approval of VOWST, the first FDA-approved orally administered microbiome-based therapeutic. Bringing a first-in-class live biotherapeutic through FDA approval required building chemistry, manufacturing, and quality systems for which no regulatory precedent existed. At Achieve, she leads the Company’s quality organization across manufacturing, clinical, and regulatory quality.

"In more than three decades in quality, I have learned that the systems you build decide whether a new drug ever reaches patients," said Ms. Cosgrove. "Taking a first-of-its-kind therapeutic through approval showed me exactly how much rigor that requires. I am here to build that same standard across both the smoking and vaping cessation programs, from clinical development through commercial supply."

Craig Donnelly has stepped down as Chief Operations Officer of Achieve, effective July 31, 2026. Responsibility for chemistry, manufacturing and controls, supply chain, and quality has transitioned to Mr. Dadino and Ms. Cosgrove. The Company thanks Mr. Donnelly for his contributions.

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 for nicotine dependence. Achieve’s New Drug Application (NDA) for cytisinicline for smoking cessation in adults is supported by two successfully completed Phase 3 studies and an open-label long-term safety study. Achieve has also completed a Phase 2 study of cytisinicline in nicotine e-cigarette cessation, conducted an end-of-Phase 2 meeting with the FDA, and has received Breakthrough Therapy designation for the vaping cessation indication.

About Cytisinicline

There are approximately 25 million adults in the United States who smoke combustible cigarettes, and tobacco use is currently the leading cause of preventable death.¹^,²

In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.¹ In 2025, approximately 1.4 million middle and high school students in the United States reported using e-cigarettes.³ 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.

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, nature and outcome of cytisinicline clinical development and regulatory review and approval, data results, the timing, nature and success of Achieve’s commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, the performance of Achieve’s third-party manufacturing partners, the successful launch and commercialization of cytisinicline, and statements concerning Achieve Life Sciences’ future plans and prospects. 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 those described in 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

¹Agaku I. Tobacco Product Use among U.S. Adults, 2023–2024, NEJM Evidence, doi: 10.1056/EVIDpha2500339.

²World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2019.

³Eunice Park-Lee, Lauren M Dutra, Hannah Cowan, et al. Tobacco Product Use Among Middle and High School Students in the United States: National Youth Tobacco Survey, 2025, Nicotine & Tobacco Research, 2026; ntag116, doi.org/10.1093/ntr/ntag116.