Manufacturing CapabilitiesAdial 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 ProgressRegulatory 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.
Strategic PartnershipsAdial announced a collaboration agreement with Genomind following successful analytical validation of a cheek swab collection method for testing patients both in clinical and commercial applications.