The FDA has granted Orphan Drug designation to Affinia Therapeutics' AFTX-201, a one-time IV gene therapy for BAG3-associated dilated cardiomyopathy. It follows a recent Fast Track grant; AFTX-201 is in the Phase 1/2 UPBEAT trial recruiting across the U.S. and Canada.
Affinia Therapeutics will present new AFTX-201 preclinical data, the UPBEAT Phase 1/2 trial design, and proprietary capsid engineering and manufacturing advancements across two oral and four poster sessions at ASGCT 2026 in Boston, May 11-15.
DemeRx announced that the FDA has accepted its IND application for DMX-1001 (oral noribogaine), a novel neuroplastogen therapeutic for the treatment of alcohol use disorder (AUD).
Affinia Therapeutics announced Health Canada’s approval of its clinical trial application for AFTX-201, a potential best-in-class investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM).
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