• Achieve Life Sciences Inc. received a Complete Response Letter (CRL) from the FDA for its cytisinicline New Drug Application (NDA) today, June 22, 2026.
  • The CRL cited manufacturing-related deficiencies at a prior third-party facility and incomplete product labeling, but identified no issues with the drug's clinical efficacy or safety.
  • The company, which anticipated the CRL, plans to resubmit its NDA in Q4 2026 with a new manufacturing partner (Adare Pharma Solutions), targeting potential FDA approval in H1 2027.