Achieve Life Sciences Announces Partnership with Adare Pharma Solutions for Cytisinicline Manufacturing 

Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

COURTESY OF ACHIEVE LIFE SCIENCES

SEATTLE and VANCOUVER, British Columbia, March 24, 2026 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Achieve) (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 financial results for the fourth quarter and full year 2025 and provided updates on the cytisinicline development program, including the announcement of its partnership with Adare Pharma Solutions (Adare).

“Achieve is fully committed to bringing cytisinicline to the millions of people who continue to struggle with nicotine dependence and need a new solution to help them quit. Much like GLP-1 therapies have transformed the way obesity is treated, shifting it from a lifestyle issue to a recognized medical condition, smoking cessation deserves the same evolution,” said Rick Stewart, President and Chief Executive Officer of Achieve. “Achieve is not quitting on smokers or people who want to quit vaping. We are relentlessly working towards the potential approval of cytisinicline, the initiation of the Phase 3 vaping trial, and a data-driven, highly targeted commercial launch approach.”

Achieve has selected Adare, based in the U.S., to manufacture cytisinicline drug product for potential commercial launch and beyond. Achieve expects this partnership will help decrease risks related to international importation of pharmaceuticals and reduce costs, including potential tariffs. Achieve has commenced the technology transfer to Adare.

In addition to potential cost-savings, the Adare partnership provides supply chain redundancy and U.S.-based contingency capacity. One manufacturer named in the cytisinicline NDA recently underwent an FDA current Good Manufacturing Practices inspection and identified two observations related to solid oral dose manufacturing, which are being addressed through an ongoing communication with FDA of its remedial action plan. The company anticipates U.S. commercial launch in the first half of 2027.

Mr. Stewart commented further, “Establishing U.S. manufacturing with Adare increases our confidence in our supply chain and continues our strong progress towards launch.”

“Our comprehensive clinical program demonstrates cytisinicline’s potential to address a persistent, public health challenge,” said Mark Rubinstein, MD, Chief Medical Officer of Achieve. “The SRNT findings are particularly encouraging because they indicate that cytisinicline helps people quit smoking regardless of their prior treatment history or number of prior attempts, and, if approved, could offer hope to those who have struggled to quit. Combined with our published research on cytisinicline’s tolerability profile, we have a comprehensive body of evidence that could represent a potential new standard of care in nicotine dependence treatment.”

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.

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, and the successful launch and 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