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4 stories mentioning ACHVUpdated 41d ago

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Wire

Achieve Life Sciences' Cytisinicline to Unlock $760 Million Market Opportunity in Smoking Cessation, Morgan Stanley Says

Achieve Life Sciences' (ACHV) Cytisinicline treatment for smoking cessation in adults will unlock about a $760 million market opportunity for the company, Morgan Stanley said in a Thursday note.The company plans to resubmit the new drug application for Cytisinicline in Q4, with potential approval from the US Food and Drug Administration in H1 2027, the brokerage noted.Achieve Life Sciences has developed an improved formulation and simpler treatment schedule for the drug, with its phase 3 study demonstrating "significantly greater" smoking abstinence rates compared with placebo, Morgan Stanley saidThe company is also evaluating Cytisinicline in e-cigarette cessation, potentially unlocking an additional $330 million market opportunity, the investment firm added.Morgan Stanley initiated coverage on Achieve Life Sciences with an overweight rating and a $13 price target.Price: $7.08, Change: $+0.39, Percent Change: +5.81%

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Research

Morgan Stanley Initiates Achieve Life Sciences at Overweight, With $13 Price Target

Achieve Life Sciences (ACHV) has an average rating of buy and mean price target of $13.91, according to analysts polled by FactSet.

$ACHV
Wire

Achieve Life Sciences Receives FDA Complete Response Letter for Cytisinicline

Achieve Life Sciences (ACHV) received a complete response letter from the US Food and Drug Administration for its new drug application for cytisinicline related to manufacturing observations at a third-party facility, the company said Monday.The FDA identified no deficiencies related to the efficacy or safety of cytisinicline, according to a statement.The manufacturing observations involve a former third-party facility that received an Official Action Indicated classification for current good manufacturing practice matters that are not specific to cytisinicline, according to the company.Achieve Life Sciences said it expects to resubmit its new drug application in Q4 after transitioning commercial manufacturing to US-based Adare Pharma Solutions.Shares of the company were up over 8% in Monday trading.Price: $5.26, Change: $+0.41, Percent Change: +8.46%

$ACHV
Research

Canaccord Genuity Initiates Coverage on Achieve Life Sciences With Buy Rating, $13 Price Target

Achieve Life Sciences (ACHV) has an average rating of Buy and mean price target of $14.63, according to analysts polled by FactSet.

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