Canaccord Reiterates Buy Rating on Achieve Life Sciences (ACHV)

Canaccord analyst Gary Nachmann reiterated a Buy rating and $13.00 price target on Achieve Life Sciences (NASDAQ: ACHV).

The analyst commented: "ACHV received a CRL for cytisinicline in nicotine dependence that was very anticipated, consistent with the timeline it had flagged on 4/15/26 ahead of its 6/20/26 PDUFA. This action was expected given cGMP-related observations at ACHV's former third-party fill-finish manufacturing facility in France, which had received an OAI classification (matters were not specific to cytisinicline). Importantly, the FDA's feedback in the CRL confirmed that there were no deficiencies related to cytisinicline's clinical efficacy or safety, which was good to see. We believe ACHV was able to advance substantially through the clinical components of the NDA review (though final product labeling was not completed by the PDUFA), which should support an efficient path toward approval once the outstanding manufacturing items are resolved. ACHV reaffirmed its previously stated timeline of an expected NDA resubmission in 4Q26 and potential approval of cytisinicline in 1H27 (followed by a U.S. commercial launch), which was also good to see. ACHV has already transitioned to Adare Pharma Solutions as its primary commercial manufacturing partner, which will be in the resubmitted NDA and completed key technology transfer activities supporting the 4Q resubmission timeline. Now that we've got past the CRL, investor focus should shift to what we believe is a low-risk regulatory path from here and a very sizeable market opportunity for cytisinicline for nicotine dependence (initially smoking cessation to be followed by vaping). Reiterate our BUY and $13 PT."

For an analyst ratings summary and ratings history on Achieve Life Sciences click here. For more ratings news on Achieve Life Sciences click here.

Shares of Achieve Life Sciences closed at $5.10 yesterday.

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