AFTX-201

Drug

Related News

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.