Achieve Life Sciences: Maintaining 'Buy' On Upcoming PDUFA And Expansion Into Vaping Cessation

2026-03-26 13:28:50 ET

The last time I spoke about Achieve Life Sciences ( ACHV ), it was with a Seeking Alpha article entitled " Achieve: Expedited Review Of Cytisinicline Sets The Stage For Development Expansion ." With respect to this article, I already mentioned that the company had its New Drug Application [NDA] of cytisinicline as a new treatment option for smoking cessation in adults accepted by the FDA , and a Prescription Drug User Fee Act [PDUFA] date of June 20, 2026, was set up. This is thanks to the ORCA-2 and ORCA-3 phase 3 studies, which showed that this drug given three times daily [TID] either every 6 weeks or every 12 weeks along with behavioral support had patients achieve statistically significant greater smoking abstinence than the patients given placebo over an extended period of time. Today, I'm going to maintain the "Buy" rating that I had set last time around. The reason why is because this date is still approaching; thus, it remains to be seen if it is ultimately approved for U.S. marketing by the FDA. However, there have been a few updates since then relating to this program....

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