AAVantgarde Bio announces FDA fast track designation for AAVB-039 for the treatment of Stargardt disease

AAVantgarde Bio

12 August 2025 - AAVantgarde Bio today announced that the US FDA has granted fast track designation for AAVB-039, the company’s gene therapy program for Stargardt disease secondary to biallelic mutation in ABCA4.

AAVB-039 addresses the underlying genetic cause of the disease by providing the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations.

Read AAVantgarde Bio press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

US , Gene therapy , Fast track