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FDA Grants Orphan Drug Designation to Affinia Therapeutics’ AFTX-201 for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM)

calendar_today July 22, 2026 person Kathy Vincent domain affinia-therapeutics

AFTX-201 is a potential best-in-class investigational genetic medicine given as a simple one-time IV infusion designed to address the underlying mutation responsible for BAG3 DCM AFTX-201 is being evaluated as a treatment for BAG3-associated DCM in the UPBEAT© clinical trial actively recruiting at multiple sites in the U.S. and Canada BAG3 DCM leads to early […] The post FDA Grants Orphan Drug Designation to Affinia Therapeutics’ AFTX-201 for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM) appeared first on AffiniaTX .

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