{"id":974211,"date":"2026-06-22T08:34:54","date_gmt":"2026-06-22T12:34:54","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/"},"modified":"2026-06-22T08:34:54","modified_gmt":"2026-06-22T12:34:54","slug":"achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/","title":{"rendered":"Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>CRL Cites Deficiencies at Third-Party Manufacturing Facility<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>No Efficacy or Clinical Safety Deficiencies Identified<\/em><br \/>\n        \n      <\/p>\n<p>SEATTLE and VANCOUVER, British Columbia, June  22, 2026  (GLOBE NEWSWIRE) &#8212; 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 of nicotine dependence, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA\u2019s action date. The FDA identified no deficiencies regarding the clinical efficacy or safety of cytisinicline.<\/p>\n<p>The deficiencies cited in the CRL concern Achieve&#8217;s prior third-party manufacturing facility, which received an Official Action Indicated (OAI) classification from the FDA for general cGMP matters at the facility that are not specific to cytisinicline. As the Company disclosed on April 15, 2026, it expected to receive this CRL on or before its June 20, 2026 PDUFA date and had previously partnered with U.S.-based Adare Pharma Solutions (Adare) as its new primary commercial manufacturing partner.<\/p>\n<p>Achieve has completed the analytical method technology transfer to Adare\u2019s facility, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the site. Achieve intends to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner, with potential FDA approval in the first half of 2027, followed by U.S. commercial launch.<\/p>\n<p>\u201cThe FDA\u2019s feedback provides a clear and actionable path forward,\u201d stated Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. \u201cOur clinical data stands on its own: two successful Phase 3 trials and a robust open-label safety study. As we work with the FDA to resolve these remaining requirements, we are simultaneously advancing our commercial readiness for launch. We remain fully committed to bringing this treatment to the patients who need it.\u201d<\/p>\n<p>The cytisinicline NDA is supported by a comprehensive clinical development program with more than 1,500 clinical trial participants exposed to cytisinicline. In the pivotal Phase 3 ORCA-2 and ORCA-3 trials, cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater smoking abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo. Safety data includes over 400 participants who received at least six months of cumulative cytisinicline exposure and over 200 participants who received at least one year of cumulative exposure. This long-term safety data was previously reported and presented at the American Thoracic Society (ATS) International Conference in May 2026.<\/p>\n<p>\n        <strong>About Cytisinicline<\/strong><br \/>\n        <br \/>There are approximately 25 million adults in the United States who smoke combustible cigarettes.\u00b9 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.\u00b2<sup>,<\/sup>\u00b3<\/p>\n<p>In addition, there are nearly 18 million adults in the United States who use e-cigarettes, also known as vaping.\u00b9 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.\u2074 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. FDA has awarded the Commissioner\u2019s National Priority Voucher for e-cigarette or vaping cessation and granted Breakthrough Therapy designation to address this critical need.<\/p>\n<p>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.<\/p>\n<p>\n        <strong>About Achieve Life Sciences, Inc.<\/strong><br \/>\n        <br \/>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. Achieve\u2019s 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.<\/p>\n<p>\n        <strong>Forward Looking Statements<\/strong><br \/>\n        <br \/>This press release contains forward-looking statements within the meaning of the \u201csafe harbor\u201d 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\u2019s 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\u2019s third-party manufacturing partners, the successful launch and commercialization of cytisinicline, and statements concerning Achieve Life Sciences\u2019 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\u2019s 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\u2019s 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.<\/p>\n<p>\n        <strong>Achieve Contact<\/strong><br \/>\n        <br \/>\n        <strong>Nicole Jones<\/strong><br \/>\n        <br \/>VP, Strategic Communications and Stakeholder Relations<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=t9UHMm04_wc1qYyqRr3eat1Fz_OgNoOrNLk-4zDhQHQujTlwi44ZDXR9MFEbF5pxUiwRDX5HXVIl8YZf8oaho0t1UjHNZofCZOS42CMEwqu7W9vxdTH7vYAWt0aAdqR_\" rel=\"nofollow\" target=\"_blank\">ir@achievelifesciences.com<\/a><br \/>425-686-1510<\/p>\n<p>\n        <strong>References<\/strong><br \/>\n        <br \/>\u00b9Agaku I. Tobacco Product Use among U.S. Adults, 2023\u20132024, NEJM, doi: 10.1056\/EVIDpha2500339.<br \/>\u00b2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.<br \/>\u00b3U.S. Department of Health and Human Services. The Health Consequences of Smoking \u2014 50 Years of Progress. A Report of the Surgeon General, 2014.<br \/>\u2074Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students \u2014 National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917\u2013924.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTc1MDEzMyM3NjcwOTkzIzIwMDM4Mjk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZDAwYzFmYTUtNjQ0NC00MGQ4LTgzYzQtMmNlYWQ1YThiNjljLTEwMTU0MDItMjAyNi0wNi0yMi1lbg==\/tiny\/Achieve-Life-Sciences-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CRL Cites Deficiencies at Third-Party Manufacturing Facility No Efficacy or Clinical Safety Deficiencies Identified SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE) &#8212; 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 of nicotine dependence, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA\u2019s action date. The FDA identified no &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-974211","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CRL Cites Deficiencies at Third-Party Manufacturing Facility No Efficacy or Clinical Safety Deficiencies Identified SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE) &#8212; 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 of nicotine dependence, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA\u2019s action date. 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(Achieve or the Company) (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 that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA\u2019s action date. The FDA identified no &hellip; Continue reading \"Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/","og_site_name":"Market Newsdesk","article_published_time":"2026-06-22T12:34:54+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTc1MDEzMyM3NjcwOTkzIzIwMDM4Mjk=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA","datePublished":"2026-06-22T12:34:54+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/"},"wordCount":1046,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTc1MDEzMyM3NjcwOTkzIzIwMDM4Mjk=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda\/","name":"Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA - 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