Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for cytisinicline, a treatment for nicotine dependence.

The FDA cited manufacturing-related deficiencies at a third-party facility, which received an Official Action Indicated classification for general current Good Manufacturing Practice matters not specific to cytisinicline. The agency identified no deficiencies related to the clinical efficacy or safety of the drug.

The CRL also noted that final product labeling was not completed by the FDA's action date of June 20, 2026. Achieve had disclosed on April 15, 2026 that it expected to receive the CRL on or before that date.

Achieve said it has already transitioned to a new manufacturing partner, U.S.-based Adare Pharma Solutions. The company said it has completed analytical method technology transfer to Adare's facility, manufactured its first engineering batch, and qualified all testing procedures at the site.

Achieve plans to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner, with a potential FDA approval targeted for the first half of 2027.

"The FDA's feedback provides a clear and actionable path forward," said Andrew D. Goldberg, MD, Chief Executive Officer of Achieve. "Our clinical data stands on its own: two successful Phase 3 trials and a robust open-label safety study."

The cytisinicline NDA is supported by data from more than 1,500 clinical trial participants. In the Phase 3 ORCA-2 and ORCA-3 trials, cytisinicline demonstrated greater smoking abstinence rates compared to placebo at end of treatment and through week 24.