AC Immune SA’s stock ACIU soared 13% premarket Tuesday, after the Swiss-based biotech said it has received U.S. Food and Drug Administration fast-track designation for an Alzheimer’s disease treatment. The treatment, called ACI-24.060, is an anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate. The fast-track designation aims to accelerate the approval of treatments for serious illnesses with unmet medical needs. The move comes after the FDA cleared the company’s investigational New Drug application, which will allow it to expand to the U.S. its current Phase 1b/2 ABATE study in patients with Alzheimer’s disease and individuals with Down Syndrome. The company has already dosed a first individual with Down Syndrome. It expects safety and immunogenicity data in both cohorts in the second half of 2023. AC Immune’s stock is down 2% in the year to date, while the S&P 500 SPX has gained 13%.
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