Raymond James reinstated coverage of Achieve Life Sciences on June 26, 2026, with a Strong Buy rating and a $20 price target. This endorsement follows a June 22, 2026, Complete Response Letter (CRL) from the FDA regarding cytisinicline, a smoking cessation therapy.
The FDA cited manufacturing deficiencies at a third-party facility rather than issues with drug safety or efficacy. Achieve has already partnered with Adare Pharma Solutions to address these concerns. The company plans to resubmit its New Drug Application in the fourth quarter of 2026.
Achieve targets a potential commercial launch in the first half of 2027. Analysts note that cytisinicline could be the first new FDA-approved smoking cessation treatment in nearly two decades. Clinical trials showed a superior efficacy and safety profile for the drug.
The market reacted positively to the news that the CRL contained no clinical hurdles. Shares rose as investors focused on the clarified path toward regulatory approval.