# Cytisinicline PDUFA Event: Nicotine dependence for smoking cessation Canonical URL: https://biopharmsignal.com/pdufa-calendar/ACHV/cytisinicline-smoking-cessation Ticker: ACHV Company: Achieve Life Sciences Event date: 2026-06-20 Event type: FDA Decision Stage: PDUFA Result: Complete Response Letter Result date: 2026-06-22 Application type: NDA FDA issued a Complete Response Letter. FDA cited unresolved cGMP observations at a former third-party manufacturing facility and final product labeling that... ## Event Timeline ### June 22, 2026 — FDA issued a Complete Response Letter FDA cited unresolved cGMP observations at a former third-party manufacturing facility and final product labeling that was not completed by the action date. The agency identified no deficiencies in cytisinicline's clinical efficacy or safety. [Achieve — Cytisinicline Complete Response Letter](https://ir.achievelifesciences.com/news-events/press-releases/detail/264/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda) ### May 19, 2026 — ORCA-OL long-term safety data were presented at ATS The 52-week open-label exposure study identified no new safety signals and completed the long-term safety evidence package supporting the smoking-cessation NDA. [Achieve — ORCA-OL 52-week safety results](https://ir.achievelifesciences.com/news-events/press-releases/detail/262/achieve-life-sciences-presents-safety-data-from-52-weeks-of-continuous-cytisinicline-treatment) ### April 15, 2026 — Achieve disclosed the third-party manufacturing issue Achieve reported that the former contract manufacturer's facility had received an Official Action Indicated classification for general cGMP matters unrelated specifically to cytisinicline and said it expected a CRL by the June 20 PDUFA date. [Achieve — Manufacturing and regulatory update](https://achievelifesciences.com/achieve-announces-operational-progress-including-completion-of-technology-transfer-to-adare-pharma/) ### September 3, 2025 — FDA accepted the NDA for review FDA accepted the cytisinicline NDA and assigned a June 20, 2026 PDUFA target action date. The filing was supported by the pivotal ORCA-2 and ORCA-3 trials and long-term ORCA-OL safety data. [Achieve — FDA acceptance of cytisinicline NDA](https://d1io3yog0oux5.cloudfront.net/_65964a4cf8dab2b8c43dc48191149dd2/achievelifesciences/news/2025-09-03_Achieve_Life_Sciences_Announces_FDA_Acceptance_of__238.pdf) ### June 26, 2025 — Achieve submitted the cytisinicline NDA Achieve submitted the application for adult smoking cessation based on two positive placebo-controlled Phase 3 studies and the required long-term exposure package. [Achieve — Cytisinicline NDA submission](https://d1io3yog0oux5.cloudfront.net/_9afbe2d312feb6071b9ad03a1a05006c/achievelifesciences/news/2025-06-26_Achieve_Life_Sciences_Announces_Submission_of_NDA__229.pdf) ### April 21, 2025 — ORCA-3 results were published in JAMA Internal Medicine The confirmatory Phase 3 publication reported significantly increased smoking cessation, reduced nicotine craving and favorable tolerability with both evaluated cytisinicline treatment durations. [Achieve — ORCA-3 JAMA Internal Medicine publication](https://ir.achievelifesciences.com/news-events/press-releases/detail/224/achieve-life-sciences-announces-cytisinicline-phase-3-orca-3-trial-publication-on-smoking-cessation-in-jama-internal-medicine) ### July 11, 2023 — ORCA-2 results were published in JAMA The first pivotal Phase 3 trial publication showed that 6- and 12-week cytisinicline regimens produced significantly higher biochemically verified smoking-abstinence rates than placebo and were well tolerated. [Achieve — ORCA-2 JAMA publication](https://ir.achievelifesciences.com/news-events/press-releases/detail/178/achieve-life-sciences-announces-publication-of) ### May 23, 2023 — ORCA-3 reported positive topline results The confirmatory Phase 3 trial met its primary and secondary smoking-cessation endpoints for both 6- and 12-week treatment durations, with low adverse-event rates. [Achieve — Positive ORCA-3 topline results](https://ir.achievelifesciences.com/news-events/press-releases/detail/175/achieve-life-sciences-reports-statistically-significant-smoking-cessation-benefit-for-cytisinicline-in-second-confirmatory-phase-3-clinical-trial) ### April 27, 2022 — ORCA-2 reported positive topline results The Phase 3 study met its primary and secondary endpoints, showing substantially higher odds of smoking abstinence with cytisinicline than placebo. [Achieve — Positive ORCA-2 topline results](https://ir.achievelifesciences.com/news-events/press-releases/detail/141/achieve-life-sciences-announces-successful-statistically-significant-smoking-cessation-results-in-phase-3-orca-2-clinical-trial-of-cytisinicline-in-adult-smokers) ### January 20, 2022 — Phase 3 ORCA-3 study started The randomized, double-blind confirmatory study began evaluating 6- and 12-week cytisinicline regimens against placebo in adults seeking to quit smoking. [ClinicalTrials.gov — ORCA-3 study record (NCT05206370)](https://clinicaltrials.gov/study/NCT05206370) ### October 2020 — Phase 3 ORCA-2 study started The first U.S. pivotal trial began enrolling adult daily smokers across 17 sites and evaluated two cytisinicline treatment durations through 24 weeks. [ClinicalTrials.gov — ORCA-2 study record (NCT04576949)](https://clinicaltrials.gov/study/NCT04576949) ## Related Pages - ACHV PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/ACHV.md - ACHV company profile: https://biopharmsignal.com/company/ACHV.md - PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md ## Related News - 2026-09-03 — Achieve Life Sciences Announced Granting of New Hire Inducement Awards: https://biopharmsignal.com/news/ACHV/achieve-life-sciences-announced-granting-of-new-hire-inducement-awards-b7010265.md - 2026-08-11 — Achieve Life Sciences Reports Second Quarter 2026 Financial Results and Provides Business Updates: https://biopharmsignal.com/news/ACHV/achieve-life-sciences-reports-second-quarter-2026-financial-results-and-provides-c8b08d84.md - 2026-08-03 — Achieve Life Sciences Appoints Ronald Dadino and Gloria Cosgrove to Lead CMC, Supply Chain, and Quality: https://biopharmsignal.com/news/ACHV/achieve-life-sciences-appoints-ronald-dadino-and-gloria-cosgrove-to-lead-cmc-sup-fde99cb7.md - 2026-07-31 — Achieve Life Sciences Announced Granting of New Hire Inducement Awards: https://biopharmsignal.com/news/ACHV/achieve-life-sciences-announced-granting-of-new-hire-inducement-awards-925196f6.md - 2026-06-29 — Achieve Life Sciences Joins Russell 2000® Index: https://biopharmsignal.com/news/ACHV/achieve-life-sciences-joins-russell-2000-index-26eba5ff.md