AC Immune SA (ACIU) News & EventsACIUAC Immune SA

AC Immune Receives FDA Fast Track Designation for Parkinson's Drug

AC Immune announced that it has received fast track designation and clearance of its investigational new drug, or IND, application from the FDA for its wholly owned anti-alpha-synuclein active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson's disease. ACI-7104 is designed to induce a-syn-specific antibodies, preferentially recognizing aggregated a-syn species that are toxic to neurons. The candidate is currently being investigated in the VacSYn Phase 2 trial, an adaptive, biomarker-based study in patients with early-stage Parkinson's disease, with final Part 1 week-100 results on track to be announced in H2.

AC Immune Releases Interim Data from Alzheimer's Trial

AC Immune announced interim data from the first three cohorts of 74 patients with prodromal Alzheimer's disease in the Phase 1b/2 ABATE trial following 12 months of treatment with ACI-24 anti-amyloid beta active immunotherapy. ACI-24 anti-Abeta active immunotherapy generally safe and well tolerated in first three Alzheimer's disease cohorts in ABATE Anti-Abeta antibody dose-response demonstrated with antibodies detected at all dose levels in cohorts AD1-3 Ongoing AD4 cohort includes additional adjuvant designed to enhance ACI-24 responses. In the trial to date, ACI-24 has been generally safe and well tolerated, with no evidence of amyloid-related imaging abnormalities-edema. Anti-Abeta antibody responses were detected at every dose level with a dose response. The company evaluated enhancing ACI-24 with an additional adjuvant to boost immunogenicity while the ABATE trial was ongoing. This is currently being tested in the recently initiated ABATE Cohort AD4.

AC Immune Presents New ALS Study Data

AC Immune SA announced the presentation of new preliminary data from a Phase 1 trial of its first-in-class TDP-43 positron emission tomography tracer ACI-19626 showing increased uptake in the brains of patients with amyotrophic lateral sclerosis. The results presented at the 2026 TDP43 Summit in Madison, Wisconsin, demonstrate that PET scans with ACI-19626 showed tracer uptake significantly higher in key regions of the brain in patients with ALS compared to healthy controls. Specifically, tracer uptake was higher in the brain stem and precentral gyrus, where TDP-43 pathology is expected to accumulate based on post-mortem neuropathology studies and on clinical symptoms. Previously reported data showed significantly higher tracer uptake in disease-relevant subcortical and cortical regions in patients with genetic frontotemporal dementia.