ACIU - AC Immune gains 14% on FDA fast track tag for Alzheimer's vaccine

2023-06-27 08:44:11 ET

Swiss biotech AC Immune SA ( NASDAQ: ACIU ) added ~14% pre-market Tuesday after announcing that the FDA issued Fast Track designation for its anti-amyloid vaccine ACI-24.060 as a treatment for Alzheimer’s disease (AD).

The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. Companies with Fast Track Designations, subject to conditions, can secure the FDA’s Accelerated Approval and Priority Review, enabling patients to access those treatments sooner.

Previously, the FDA had cleared AC Immune’s ( ACIU ) Investigational New Drug (IND) application for ACI-24.060, allowing the company to expand its ongoing Phase 1b/2 ABATE study in the U.S. for patients with AD and Down syndrome.

The FDA’s decision was based on data from ABATE’s first, low-dose AD cohort, AC Immune ( ACIU ) said, adding that the company has started dosing in a second, higher-dose AD cohort in the trial.

ACIU expects a key interim readout from ABATE in the first half of next year, medical chief Johannes Streffer said, while CEO Andrea Pfeifer explained: "We look forward to showing in H1 2024 the effect of ACI-24.060 on amyloid plaque reduction, a surrogate marker for disease modification."

More on AC Immune

• AC Immune rises ~10% as Alzheimer’s vaccine shows promise in early-stage trial
• AC Immune: Dementia-Focused Swiss Biotech With A Sad History Of Failures

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