AC Immune's stock soars 13% after FDA grants fast-track designation to Alzheimer's treatment

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 has gained 13%.

-Ciara Linnane

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

06-27-23 0753ET

Copyright (c) 2023 Dow Jones & Company, Inc.