Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Results; Announces Adare Pharma Solutions Partnership and Key Regulatory Milestones

Key Highlights for Investors

• Acceptance of Cytisinicline NDA by FDA: The U.S. Food and Drug Administration (FDA) has accepted Achieve Life Sciences’ New Drug Application (NDA) for cytisinicline, a novel treatment for nicotine dependence. The FDA has set a Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026. This is a major regulatory step, positioning cytisinicline as a potential new standard of care for smoking cessation in adults.
• Adare Pharma Solutions Partnership: Achieve has entered into a partnership with U.S.-based Adare Pharma Solutions for the manufacturing of cytisinicline. This move is expected to minimize supply chain risks, reduce costs (including tariffs), and provide redundancy and contingency capacity within the U.S. The tech transfer to Adare has already commenced, which could accelerate commercial readiness and mitigate regulatory and logistical risks related to international manufacturing.
• Regulatory and Clinical Progress:
  • The company has completed the ORCA-OL long-term exposure trial, with 334 participants finishing the one-year study, providing robust long-term safety data. This exceeds the number of patients typically required by FDA for review.
  • Cytisinicline was selected as one of the inaugural therapies for the FDA Commissioner’s National Priority Voucher program for e-cigarette/vaping cessation, which is intended to expedite regulatory review for this high-priority area.
  • Publication of pivotal Phase 3 (ORCA-3) data in JAMA Internal Medicine confirmed cytisinicline’s efficacy and tolerability for smoking cessation at both 6- and 12-week treatment durations, with additional benefits in craving reduction and prolonged abstinence. New data in Thorax also demonstrated effectiveness in COPD and non-COPD populations.
• Commercial Preparations Underway: Achieve has completed supply chain and market access readiness activities, including implementation of third-party logistics and specialty pharmacy partner selection. The company also announced a partnership with Omnicom for a data-driven, multi-agency commercial model to support a targeted and efficient product launch.
• Financial Position:
  • As of December 31, 2025, Achieve had cash, cash equivalents, and marketable securities totaling \$36.4 million, up from \$34.4 million the prior year.
  • Total operating expenses for Q4 and FY2025 were \$14.7 million and \$54.9 million, respectively. Net losses for the same periods were \$14.7 million and \$54.7 million.
  • Weighted average shares outstanding increased to 53.3 million in Q4 2025, indicative of probable capital raises, warrant exercises, or equity issuances during the year.

Detailed Business and Regulatory Update

Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company, reported its results for the fourth quarter and full year ended December 31, 2025. The company is focused on the global development and commercialization of cytisinicline, a therapy for nicotine dependence and smoking cessation.

CEO Commentary

“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. 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.”

— Rick Stewart, President and CEO

Manufacturing and Supply Chain Moves

• Achieve’s selection of Adare Pharma Solutions as a U.S.-based manufacturer is specifically intended to reduce risks associated with international importation, including tariffs and regulatory delays. The transition provides redundancy and contingency capacity, bolstering supply chain reliability in preparation for commercial launch.
• One manufacturer listed in the cytisinicline NDA recently underwent an FDA inspection resulting in two observations for which a remedial action plan is being implemented. The company anticipates that these actions, combined with Adare’s involvement, will support a U.S. commercial launch in the first half of 2027.

Clinical and Regulatory Milestones

• NDA Acceptance and PDUFA Date: The FDA accepted the NDA for cytisinicline for smoking cessation in adults, with a June 20, 2026, PDUFA date.
• ORCA-OL Long-Term Safety Study: 334 participants completed the one-year exposure study, providing extensive safety data, which strengthens the NDA submission and regulatory review process.
• National Priority Voucher: Cytisinicline is one of only nine therapies selected for the inaugural FDA Commissioner’s National Priority Voucher for e-cigarette/vaping cessation, potentially enabling expedited review.
• Clinical Publications and Data:
  • ORCA-3 results published in JAMA Internal Medicine validate cytisinicline’s efficacy and safety.
  • Data in Thorax show cytisinicline increases smoking abstinence in both COPD and non-COPD patients. Quit rates for COPD patients, who generally have higher tobacco dependence and prior treatment exposure, were comparable to non-COPD participants.
  • Presentations at the 2026 Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting demonstrated cytisinicline’s efficacy regardless of previous cessation medication use or quit attempts, and included post-trial survey data about extended use over one year.

Market Opportunity

• Approximately 25 million adults in the U.S. smoke combustible cigarettes. Tobacco use remains the leading cause of preventable death, responsible for over 8 million deaths globally and nearly 500,000 deaths in the U.S. annually.
• Nearly 18 million adults in the U.S. use e-cigarettes, with 1.6 million middle and high school students reporting e-cigarette use in 2024. There are currently no FDA-approved treatments specifically for nicotine e-cigarette cessation.
• Cytisinicline is plant-based, believed to work by binding to nicotinic acetylcholine receptors in the brain, reducing cravings and the reward associated with nicotine use.

Financial Results Snapshot

Important Shareholder Considerations and Potential Price-Sensitive Elements

• Regulatory Approvals: The NDA acceptance and assignment of a June 2026 PDUFA date are significant milestones. Any updates, delays, or positive outcomes here are likely to be highly price sensitive.
• Manufacturing and Supply Chain Risk Mitigation: The move to establish U.S.-based manufacturing with Adare Pharma Solutions, combined with the management of FDA inspection findings, reduces key regulatory and operational risks that could otherwise impact timelines and value.
• Commercial Readiness: Announcements of supply chain, pharmacy, and marketing partnerships signal that Achieve is preparing for a rapid and targeted launch upon approval, which could improve market uptake and revenue ramp post-approval.
• Cash Runway and Funding Needs: The company’s cash position of \$36.4M will be closely watched, as ongoing development, regulatory, and pre-launch activities are likely to require additional capital prior to commercial launch in 2027.
• Market Size and Unmet Need: The large addressable market in both smoking and vaping cessation, coupled with the lack of FDA-approved treatments for nicotine e-cigarette cessation, creates significant upside potential if cytisinicline is approved and successfully commercialized.
• Clinical Data: Strong clinical outcomes published in major journals and presented at key conferences further validate the drug’s profile and market potential, providing important de-risking for investors.

Conference Call Information

Achieve will host a conference call at 8:30 a.m. EDT on March 24, 2026. Investors can access the webcast or join via phone. A replay will be available for 90 days post-call.

About Achieve Life Sciences and Cytisinicline

Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline, a plant-based alkaloid for nicotine dependence. Cytisinicline is currently investigational and has not been approved by the FDA for any indication in the U.S.

Disclaimer

This article is for informational purposes only and is not investment advice. Forward-looking statements in the company’s report are subject to risks and uncertainties, including those described in Achieve Life Sciences’ filings with the SEC. Investors should conduct their own due diligence and consult with a qualified financial advisor before making any investment decisions.

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