Achieve Life Sciences (NASDAQ:ACHV) used its first-quarter 2026 earnings call to outline a transition period marked by new leadership, a major financing, manufacturing changes tied to its cytisinicline regulatory timeline and preparations for a potential commercial launch in 2027.
Dr. Andrew Goldberg, Achieve’s new chief executive officer, said he joined the company at “an important time” as it works to develop cytisinicline for smoking cessation and vaping cessation. Goldberg said nearly 50 million adults in the United States use nicotine, including approximately 25 million smokers and 18 million people who vape, and said current treatment options leave many patients unable to quit.
“Despite the scale of this problem, there has not been a new FDA-approved smoking cessation therapy in more than 2 decades, and there has never been an approved therapy for vaping cessation,” Goldberg said.
Company Raises Capital as It Prepares for Approval and Launch
Goldberg highlighted Achieve’s recently completed private placement, which included $180 million in upfront capital and up to $174 million from milestone-based warrants. The warrants may be exercised at any time prior to and up to 20 trading days following FDA approval, he said.
Goldberg said the financing gives Achieve the resources to execute its strategy and prepare for launch. He said the company now plans to commercialize cytisinicline independently with its own field force, adding that Achieve believes it is “best positioned to bring cytisinicline to patients ourselves.”
The company also announced additions to its board and commercial team. Goldberg said Achieve appointed Chris Martin, most recently chief commercial officer of Verona Pharma; Dr. Lucian Iancovici, managing director at TPG; and Dr. Aaron Royston, managing partner at venBio, to its board. Achieve also added two former Verona executives to its commercial organization: Mark Zappia as senior vice president of commercial and Jim Willis as vice president of sales and enablement.
Goldberg said the new commercial leaders bring experience from the launch of Verona’s Ohtuvayre, which he described as “widely regarded as one of the best launches in industry history.”
Manufacturing Shift Drives Regulatory Timeline
Achieve said it expects to receive a complete response letter from the U.S. Food and Drug Administration on or by its June 20 PDUFA date because a separate third-party manufacturer received an Official Action Indicated classification. Goldberg said the observations relate to general current good manufacturing practice matters at the facility and are not specific to cytisinicline manufacturing.
The company’s plan is to resubmit the new drug application in the fourth quarter of 2026, naming U.S.-based Adare Pharma Solutions as its new and primary manufacturing partner for potential commercial supply. Achieve continues to expect a commercial launch in the first half of 2027.
Goldberg said Achieve has already produced its first cytisinicline engineering batch at Adare’s facility and has completed analytical method transfer. In response to analyst questions, he said the company no longer plans to use the manufacturer that received the OAI classification as part of its path forward.
“Our principal goal and my principal goal is completing that tech transfer to Adare on as fast a timeline as possible while maintaining our completeness,” Goldberg said. He added that he had already visited Adare’s headquarters and said Achieve is confident its U.S. partner, which he said has multiple FDA-approved products, can support the company’s plans.
Clinical Data Remains Central to Cytisinicline Case
Goldberg also reviewed recent scientific updates supporting cytisinicline. In March, Achieve published mechanistic data in Nicotine & Tobacco Research showing that cytisinicline selectively interacts with the alpha-4 beta-2 nicotinic receptor while showing minimal interaction with the 5-HT3 serotonin receptor. Goldberg said that mechanism may help explain the low nausea rates observed in clinical trials.
At the Society for Research on Nicotine & Tobacco conference, Achieve presented an analysis of more than 1,600 Phase III participants. Goldberg said the analysis showed consistent efficacy regardless of prior treatment history or previous quit attempt patterns.
Among participants with prior varenicline and bupropion use, those receiving 12 weeks of cytisinicline achieved continuous abstinence rates of 32.4%, compared with 6% for placebo, with an odds ratio of 7.5, Goldberg said. He described that group as a difficult-to-treat population and said the data highlight cytisinicline’s potential among patients who have not succeeded with existing therapies.
Goldberg said Achieve expects to present additional data later this year, including information on patients with cancer, and noted that the company has previously described cytisinicline’s performance in patients with chronic obstructive pulmonary disease.
Commercial Strategy to Focus on Prescribers and Access
During the question-and-answer session, Goldberg said the company now has the resources to pursue a broader commercial strategy. He said nicotine dependence differs from some other disease categories because patients often already know they have the condition and are already interacting with healthcare providers.
“The barrier to treatment has not been awareness of the disease,” Goldberg said. “It’s been the lack of an effective and tolerable therapy that prescribers feel confident offering.”
Goldberg said Achieve’s launch strategy will focus on giving prescribers a reason to treat, equipping them with the right therapy and reducing access friction. He declined to specify the expected size of the field force, saying the company intends to scale “in accordance” with broader distribution and remain disciplined in how it builds the team.
He also said patient support programs could be part of the company’s future commercial approach, citing the availability of digital and telehealth infrastructure.
Vaping Program Expected to Advance
Achieve also addressed its vaping cessation program. Goldberg said the company’s smoking cessation NDA “stands on its own two feet,” supported by two Phase III double-blind, placebo-controlled trials in which both six-week and 12-week courses reached statistical significance.
Goldberg said the vaping indication is a follow-on program and noted that Achieve has received both a CNPV voucher and Breakthrough Designation. He said ORCA-V2, the company’s planned Phase III vaping study, will be a randomized, placebo-controlled, multicenter trial. Achieve is finalizing the design and hopes to initiate the study this year, he said.
In closing remarks, Goldberg said investors should focus on three points from the quarter: Achieve’s strengthened capital position, its U.S.-based supply chain and the addition of commercial leadership with relevant launch experience. “Achieve is positioned to address one of the largest preventable public health problems we know,” he said.
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.
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