Alzinova secured FDA approval to advance its novel Alzheimer’s vaccine candidate ALZ-101 into Phase II clinical testing in the United States. ALZ-101 is designed to stimulate antibodies targeting toxic amyloid-beta oligomers, implicated in early Alzheimer’s pathology. Favorable safety and immunogenicity results from Phase Ib support progression to larger populations. This vaccine approach aims to modify disease course beyond symptomatic management by harnessing active immunotherapy at initial pathogenic stages. The trial represents a critical step toward validating the clinical potential of ALZ-101 as a disease-modifying Alzheimer’s intervention.