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March 5, 2026

Affinia receives FDA fast track designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) fast track designation (FTD) for AFTX-201, a genetic medicine under investigation for treating Bcl-2-associated athanogene 3 (BAG3)-associated dilated cardiomyopathy (DCM).

The therapy is being evaluated in the ongoing Phase I/II UPBEAT clinical trial in BAG3 DCM patients. Credit: NMK-Studio / Shutterstock.com.