News Related to AFTX-201

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January and March 2026 drug pipeline updates span Phase 3, Fast Track and Priority Review

Apr 23, 2026

January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.

Affinia Therapeutics Receives FDA Fast Track and EMA Orphan Drug Designations for AFTX-201

Mar 05, 2026

Affinia Therapeutics has received FDA fast track designation and EMA orphan drug designation for AFTX-201, an investigational gene therapy for BAG3-associated dilated cardiomyopathy, a rare genetic heart disease affecting over 70,000 patients.