Posted by Michael Wonder on 04 Mar 2026
Affinia Therapeutics granted FDA fast track designation for AFTX-201 as a treatment for people living with BAG3-associated dilated cardiomyopathy
4 March 2026 - Affinia Therapeutics today announced that the US FDA has granted fast track designation for AFTX-201, a potential best in class investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy.
AFTX-201 is designed to deliver a fully human, full length BAG3 transgene using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10 fold lower than those associated with gene therapies using conventional capsids such as AAV9 or AAVrh74.
