Achieve Life Sciences is trading 5.4% up today at $6.28, rebounding after a sharp decline triggered by an FDA Complete Response Letter (CRL) for cytisinicline and subsequent financing pressures.
- The CRL, disclosed in June 2026, was related to manufacturing and labeling at a third-party facility, with no issues cited regarding the drug's safety or efficacy.
- The company plans to resubmit its New Drug Application (NDA) in Q4 2026, targeting potential regulatory approval in the first half of 2027.