Achieve Life Sciences (NASDAQ:ACHV) used its fourth-quarter and full-year 2025 earnings call to outline progress toward a potential U.S. launch of cytisinicline, the company’s investigational therapy for nicotine dependence. Management emphasized that the June 2025 new drug application (NDA) submission for smoking cessation marked an inflection point, shifting the company from a “pure play clinical development” focus toward commercial readiness.
Regulatory milestones and FDA timelines
President and CEO Rick Stewart said the company’s smoking cessation NDA was accepted by the FDA, and he described the review process as involving “normal” communications for this stage. In the Q&A, Stewart stated the FDA-set PDUFA date for the smoking cessation NDA “remains the 20th of June” (as discussed on the call) and said the company continues to work toward that date.
Management said Achieve is preparing to initiate ORCA-V2, its Phase 3 vaping cessation trial. Rubinstein said groundwork is underway, including selecting trial sites and identifying principal investigators. In Q&A, management added that FDA dialogue has largely centered on protocol approval so far, with anticipated study commencement in the first half of the year (as referenced during the call).
Clinical data: long-term tolerability and subgroup efficacy
Stewart highlighted several clinical developments in 2025, including completion of the ORCA-OL long-term exposure trial. He said the study “underlined cytisinicline safety profile,” citing strong tolerability and “excellent patient satisfaction data,” and emphasized the significance of tolerability over 52 weeks of exposure.
Rubinstein added that Achieve presented a pooled analysis of more than 1,600 participants from Phase 3 trials at the Society for Research on Nicotine and Tobacco (SRNT) conference. According to Rubinstein, efficacy was consistent across participants with different prior treatment histories—including those who previously tried varenicline, bupropion, or nicotine replacement therapy—and across differing quit-attempt patterns.
The company also presented late-breaking survey data from ORCA-OL focused on voluntary, self-reported experiences among participants who continued cytisinicline beyond standard six- or 12-week courses, providing insight into long-term use up to 52 weeks. Rubinstein said participants described meaningful benefits, including successful quitting and improvements in physical health.
Stewart also pointed to post-hoc data published in Thorax showing cytisinicline significantly improved quit rates versus placebo among adults with chronic obstructive pulmonary disease (COPD). He noted there are “6 million COPD smokers in the U.S.” and characterized the data as highlighting broader opportunity across comorbidities and provider types.
During Q&A, Rubinstein addressed questions about dosing and adherence, noting that in ORCA-OL, participants took cytisinicline three times a day for up to a year. He said participants did not find the regimen excessively burdensome, adding that adherence and completion were high and that adherence in the 52-week trial was “over 75%.” He also said some participants aligned dosing with mealtimes, which they associated with higher cravings.
Commercial strategy: digital-first model and pre-launch preparation
Chief Commercial Officer Jaime Xinos said Achieve built “the foundation for a launch-ready infrastructure from the ground up” while remaining lean. She framed commercialization around three priorities:
- Availability: supply chain readiness, including progress with a third-party logistics provider, serialization, and state licensing (Xinos said the company had secured more than half of required licenses), plus administrative and logistical setup with a specialty pharmacy hub partner.
- Access: payer engagement to support coverage and affordability. Xinos said Achieve continued discussions with prioritized payers in Q1 to share clinical data and gather feedback to inform pricing, access, and contracting strategy.
- Awareness: education designed to reposition nicotine dependence as a medical condition. Stewart and Xinos highlighted the “Willpower” awareness campaign launched in January, intended to challenge the idea that quitting is only about personal determination.
Xinos said the company is building an omni-channel, digital platform intended to reach physicians and patients as access to in-person detailing declines. Stewart stated that about 75% of primary care physicians “will no longer meet with medical reps,” and he described AI and machine learning as tools to enhance decision-making, automate engagement, and generate predictive insights. Xinos also described an “AI-powered asset factory” and a partnership with Omnicom to speed development and review of messaging and materials, while maintaining regulatory compliance.
Asked about current healthcare provider awareness, Xinos said broad product awareness has not been a priority to date due in part to pre-approval communication limits. She said the company has focused on conserving resources for a stronger push closer to launch, including leveraging scientific meetings such as the American Thoracic Society (ATS) conference, where Achieve has been accepted to present in May 2026.
Manufacturing and supply chain: U.S. production and contingency planning
Stewart said Achieve selected Adare Pharma Solutions, a U.S.-based manufacturer, to produce cytisinicline drug products ahead of potential commercial launch and future demand. He said work has begun and the technology transfer is underway, positioning the partnership as a way to secure supply, reduce risks tied to international importation, and potentially reduce costs, including tariff-related uncertainty.
Stewart also disclosed that the manufacturer named in the NDA recently underwent an FDA good manufacturing practices inspection that resulted in “2 observations related to solid oral dose manufacture,” which are being addressed through ongoing communications with the FDA.
In Q&A, management said the commercial launch is expected in the first half of 2027 and characterized the timeline as driven by the need to ensure product supply and operational readiness. Stewart said adding Adare to the NDA is expected to occur post-approval; he also indicated a goal of having Adare available to be added to the NDA in the third quarter timeframe discussed on the call.
Stewart provided additional supply chain color regarding raw plant material, saying Achieve has been stockpiling starting material and expects to have more than three years of supply by launch for expected market needs. He said the company intends to maintain inventory at roughly that level and described reprocessing material as needed.
He also discussed Sopharma AD, noting it was not included in the current NDA due to concerns about FDA inspection readiness, but said the company has seen progress and intends to add Sopharma after NDA approval.
Financial results and payer engagement
Chief Financial Officer Mark Oki reported that as of December 31, 2025, Achieve had $36.4 million in cash equivalents and marketable securities. Total operating expenses were $14.7 million for the fourth quarter and $54.9 million for the full year, reflecting investment in regulatory, clinical, and pre-commercial and commercial infrastructure. Net loss totaled $14.7 million for the quarter and $54.7 million for the year. Oki said the company continues evaluating financing options and cash management strategies.
On payer strategy, Xinos said Achieve has been engaging payers through pre-approval information exchange, citing “about 40 touch points with payers” in the first quarter and participation at PCMA. She said some payers have proactively requested discussions, and she cited the Affordable Care Act requirement for coverage of smoking cessation treatment as supportive of access. Still, Xinos said the company expects a “slow ramp” in the first six months after launch as formulary placement expands and initial access restrictions are worked through.
Management declined to discuss specific pricing. In response to a question about an ICER report, Xinos said Achieve participated in the process by providing information when requested and said the report affirmed substantial unmet need and recommended payers make cytisinicline immediately available, but she said the company has not set pricing yet.
About Achieve Life Sciences (NASDAQ:ACHV)
Achieve Life Sciences, Inc (NASDAQ: ACHV) is a clinical-stage biotechnology company dedicated to the development and commercialization of cytisinicline, a plant-derived alkaloid for smoking cessation. The company’s mission is to offer a novel, evidence-based therapy that addresses the global need for effective and well-tolerated smoking cessation options. Achieve focuses its efforts on advancing the clinical profile of cytisinicline through rigorous development programs and regulatory engagement.
Cytisinicline (formerly marketed as Tabex® in Europe) acts as a nicotinic acetylcholine receptor partial agonist, helping reduce withdrawal symptoms and nicotine cravings.
