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ACHV 资讯
ACHV 事件
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.
Achieve Life Sciences Files Prospectus for Resale of 49.42M Shares
Achieve Life Sciences filed a prospectus relating to the resale by selling shareholders, from time to time, of up to 49.42M shares of common stock.
Achieve CEO Highlights Importance of Cytisinicline
"Achieve is a mission-driven company. Nicotine dependence is one of the largest preventable public health hazards we know, and smoking remains the leading cause of preventable death," said Andrew D. Goldberg, Chief Executive Officer of Achieve. "If approved, cytisinicline would be the first new FDA-approved smoking cessation therapy in more than two decades, and could also be the first ever for vaping cessation. My job is to ensure we have the team, the capital, and the strategy to bring cytisinicline to patients."
Achieve Life Sciences Completes $354M Private Placement
Before the market opened, Achieve Life Sciences announced it had entered into a securities purchase agreement with healthcare investors for a private placement of its securities for gross proceeds up to approximately $354M, before deducting placement agent fees and other expenses, including initial upfront funding of approximately $180M and up to an additional approximately $174M on exercise of milestone-driven warrants. The private placement will be for 49.42M shares of common stock at a price of $3.635 per share, or in lieu of shares of common stock, an investor will purchase 100,500 pre-funded warrants at a purchase price of $3.634 per pre-funded warrant, and accompanying warrants to purchase up to 49,518,569 shares of common stock or pre-funded warrants, at a collective purchase price of $3.635 per share of common stock and accompanying warrant or, in lieu thereof, $3.634 per pre-funded warrant and accompanying warrant. The private placement was led by new investors Frazier Life Sciences, TPG Life Sciences Innovations, venBio Partners, Paradigm BioCapital Advisors and Marshall Wace and also includes participation from both new and existing investors, including Coastlands Capital, Dialectic Capital, Janus Henderson Investors, LifeSci Venture Partners, Logos Capital, Propel Bio Partners, Spruce Street Capital, Venrock Healthcare Capital Partners, Vivo Capital and Wellington Management.
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