Achieve Life Sciences Raises $354M, Names New CEO, Partners with Adare
Achieve Life Sciences raised $354 million in a private placement—$180 million upfront and $174 million in warrants—to fund its ORCA-V2 Phase 3 trial and commercialization of cytisinicline. The company appointed Andrew D. Goldberg as CEO, partnered with Adare Pharma for U.S. manufacturing, and targets NDA resubmission in Q4 2026.
1. Financing and trial funding
Achieve Life Sciences closed a private placement for up to $354 million, including $180 million upfront and $174 million in milestone-driven warrants, to fund its ORCA-V2 Phase 3 trial for cytisinicline, commercialization activities, and general corporate purposes.
2. Leadership transition
Andrew D. Goldberg, MD was appointed Chief Executive Officer and board member, while Lucian Iancovici, MD assumed board chair, alongside new directors Christopher Martin and Aaron E. Royston; Chief Commercial Officer Jaime Xinos and Director Tom King will depart later in 2026.
3. Manufacturing partnership and regulatory plan
The company partnered with U.S.-based Adare Pharma Solutions to transition commercial manufacturing of cytisinicline, completed technology transfer and first engineering batch qualification, and plans to resubmit its New Drug Application in Q4 2026 after its prior CMO received an FDA Official Action Indicated classification, targeting a U.S. launch in H1 2027.
4. Clinical data and outlook
Pooled Phase 3 ORCA-2 and ORCA-3 data showed cytisinicline achieved 32.4% continuous abstinence versus 6.0% for placebo (OR 7.5), while post-trial surveys reported 98% would recommend the therapy, supporting its potential as a new smoking cessation option.