Ready to use Parkinson's stem cell therapy put on FDA fast track

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)

Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance Recent positive interim results showed safety and immunogenicity with early signals of activity Full week-100 results from Part 1 of VacSYn trial expected in H2 2026   Lausanne, Switzerland, August 11, 2026 – AC Immune SA (NASDAQ: ACIU), […] The post AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-…

Ready to use Parkinson's stem cell therapy put on FDA fast track

An off-the-shelf, or ready to use, stem cell therapy that’s designed to replace the nerve cells lost in Parkinson’s disease and restore neurological function has been put on a developmental fast track by the U.S. Food and Drug Administration (FDA). The FDA awarded fast track status — a designation that could mean a faster pathway through regulatory review if clinical data are positive — to XS411, being developed by China-based Xellsmart. Clinica…