News Summary

• The U.S. Food and Drug Administration has granted AAVB-039 Orphan Drug Designation (ODD) The company has also received Clinical Trial Authorisation (CTA) approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Stargardt disease is the most common inherited form of macular degeneration and is a leading cause of vision loss in children and young adults.
• The Investigational New Drug (IND) and CTA applications have been cleared to proceed by the FDA and the MHRA.