Innovative TreatmentThe new Phase 3 study will incorporate biomarker-driven patient selection, focusing on a genetically defined subset of AUD patients, positioning AD04 as a potential first-in-class precision medicine for AUD.
Manufacturing CapabilityAdial announced securing US-based manufacturing for AD04 through agreements with Cambrex and Thermo Fisher Scientific to support P3 studies and planned NDA submission for AUD.
Regulatory ApprovalRegulatory clarity from the FDA on the Phase 3 study design resolves the primary uncertainty around the path forward for AD04, allowing the study to be viewed as partially de-risked.