Jun. 22 at 12:34 PM
$ACHV Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA
GLOBENEWSWIRE 7:30 AM ET 6/22/2026
"Achieve has completed the analytical method technology transfer to Adare’s facility, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the site. Achieve intends to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner, with potential FDA approval in the first half of 2027, followed by U.S. commercial launch."