Achieve Life Sciences, Inc. (ACHV), a late-stage pharmaceutical company, announced that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of Cytisinicline as a treatment for nicotine dependence.
The CRL cited deficiencies related to current Good Manufacturing Practice (cGMP) observations at a third-party manufacturing facility and final product labeling that was not completed by the FDA's action date. There were no discrepancies regarding the clinical efficacy or safety of cytisinicline.
Cytisinicline is a plant-derived alkaloid that exhibits a strong binding affinity for nicotine acetylcholine receptors in the brain. It is designed to mitigate the intensity of nicotine craving symptoms and to lessen the feelings of reward and satisfaction linked to nicotine products.
The FDA had previously issued an Official Action Indicated (OAI) classification to Achieve's third-party manufacturing facility. Anticipating this outcome, Achieve had partnered with U.S.-based Adare Pharma Solutions as its primary commercial manufacturing partner.
Achieve has completed the transfer of analytical testing methods to Adare, successfully manufactured its first engineering batch of cytisinicline, and qualified all testing procedures at the Adare facility.
The company plans to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner.
If the resubmitted NDA is accepted and review proceeds without additional major deficiencies, cytisinicline could receive FDA approval in the first half of 2027, followed by a U.S. commercial launch, the company noted.
ACHV is currently trading at $5.41, up 11.55%.
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