AAVantgarde Bio Announces FDA Fast Track Designation for AAVB-039 for the Treatment of Stargardt Disease

AAVantgarde Bio Announces FDA Fast Track Designation for AAVB-039 for the Treatment of Stargardt Disease

MILAN, Aug. 12, 2025 (GLOBE NEWSWIRE) -- AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing next-generation gene therapies for inherited retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AAVB-039, the company's gene therapy program for Stargardt disease secondary to biallelic mutation in ABCA4. The Investigational New Drug (IND) application for …

FDA grants Fast Track Designation to AAVantgarde Bio for AAVB-039

AAVB-039 is the company’s gene therapy program for Stargardt disease secondary to biallelic mutation in ABCA4.