Achieve Life Sciences Shares Rise After Complete Response Letter From FDA

By Chris Wack

Achieve Life Sciences shares were 7.3% higher, at $5.21, after the company said it has received a complete response letter from the Food and Drug Administration regarding its New Drug Application for cytisinicline.

The late-stage specialty pharmaceutical company said the CRL relates to outstanding manufacturing-related observations from a current good manufacturing practice inspection of a third-party manufacturing facility and to final product labeling that wasn't completed by the FDA's action date.

The company said the FDA identified no deficiencies regarding the clinical efficacy or safety of cytisinicline.

The deficiencies cited in the CRL concern Achieve's prior third-party manufacturing facility, which received an Official Action Indicated classification from the FDA for general cGMP matters at the facility that aren't specific to cytisinicline.

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.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 22, 2026 11:01 ET (15:01 GMT)