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ACHV-News
ACHV-Events
Achieve Life Sciences Reports Positive ORCA-OL Trial Results
Achieve Life Sciences announced positive 52-week efficacy results from its long-term, open-label ORCA-OL clinical trial evaluating cytisinicline for cigarette smoking and e-cigarette cessation, presented at the CHEST 2026 Annual Meeting. The trial enrolled 479 adults, of whom 475 received at least one dose of cytisinicline 3 mg three times daily for up to 52 weeks. Four-week sustained abstinence rates increased from 25.5% at weeks 9-12 to 30.3% at weeks 21-24 to 31.2% during the final four weeks of treatment in the total study population. Among participants who had received placebo in their prior trial and were still smoking or vaping, 39.4% had quit at weeks 49-52, and the independent Data Safety Monitoring Committee identified no new safety signals. "Every one of them chose to try again, and nearly a third were not smoking or vaping at the end of a year," said Andrew Goldberg, CEO.
Achieve Life Sciences Appoints Benjamin Halladay as CFO
Achieve Life Sciences announced the appointment of Benjamin Halladay, CPA, as Chief Financial Officer, effective October 5, 2026. He will be responsible for the Company's financial strategy, accounting, investor relations, information technology, and other key administrative functions.
Stock Futures Rise, Boeing Up 3%
Stock futures were higher after the Fed's preferred gauge showed core inflation at 3.0% in August, which was lighter than expected.In pre-market trading, S&P 500 futures were up 0.34%, Nasdaq futures were up 0.5%, and Dow futures were up 0.31%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Boeingup 3% after being selected to produce the U.S. Navy's F/A-XX Strike Fighter for over $20BAchieve Life Sciencesup 4% after Stifel initiated coverage with a Buy ratingGameStopup 2% after Chairman and CEO Ryan Cohen purchased $10.6M worth of sharesRobinhoodup 5% after unveiling Robinhood Agents and extending equities trading to 24-7Vandaup 4% after saying Hetlioz met its primary endpoint in a late-stage trial for adults with Delayed Sleep-Wake Phase DisorderDOWN AFTER EARNINGS -Cal-Mainedown 7%Concentrixdown 8%FactSetdown 3%Jabil Circuitdown 3%Conagradown 3%LOWER -Northrop Grummandown 4% after Boeing was selected to build a next-generation fighter jet by the PentagonModernadown 8% after Citi downgraded the stock to Sell
Achieve CEO Highlights Cytisinicline Opportunity and Team Building
"This quarter was about building Achieve to match the significant opportunity of cytisinicline," said Andrew Goldberg, CEO of Achieve. "We added a commercial team, senior CMC and quality leadership, six new directors, and advanced the finished drug product manufacturing transition to the United States. The Complete Response Letter raised no question about the efficacy or clinical safety of cytisinicline. With the team and financing in place, our focus turns to resubmission and commercial readiness. Behind that work are millions of adults still looking for help to quit."
Achieve Life Sciences Receives Complete Response Letter from FDA
Achieve Life Sciences announced that it has received a complete response letter, or CRL, from the FDA regarding the new drug application, or NDA, for cytisinicline. 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 was not completed by the FDA's action date. 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 are not specific to cytisinicline. As the Company disclosed on April 15, 2026, it expected to receive this CRL on or before its June 20 PDUFA date and had previously partnered with U.S.-based Adare Pharma Solutions as its new primary commercial manufacturing partner. Achieve has completed the analytical method technology transfer to Adare's facility, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the site. 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.
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