AC Immune SA ACIU shares surged Tuesday after the company received FDA Fast Track Designation for its anti-amyloid-beta active immunotherapy, ACI-24.060, for Alzheimer's disease.
What To Know: The news followed FDA clearance of the Investigational New Drug application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with DS. The first individual with DS has also been dosed in ABATE.
Fast Track Designation and IND clearance were supported by initiali interim safety and immunogenicity data from ABATE's first, low dose AD cohort. Dosing in a higher dose cohort began earlier this year.
Andrea Pfeifer, CEO of AC Immune SA, stated, "We are delighted to see the quality and importance of our ACI-24.060 program reflected in the granting of Fast Track designation, which offers opportunities for expedited development and regulatory review. This regulatory progress underscores the attraction of an active immunotherapy targeting toxic species of Abeta."
Related Link: Why Generac Stock Is Rising Today
ACIU Price Action: Shares of ACIU were up 78.3% at $3.53 at the time of publication, according to Benzinga Pro.
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