The only known investigational therapy for SBMA in Phase 3 development worldwide AJ201 (rosolutamide) is an investigational oral small molecule designed to address multiple disease mechanisms of spinal and bulbar muscular atrophy (SBMA, or Kennedy's disease)
Following submission of the Phase 3 protocol to the U.S. FDA under AnnJi's active Investigational New Drug (IND) application, AnnJi will proceed with U.S. site activation for the global Phase 3 ROMA-KD trial
AJ201 has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation in both the U.S. and the European Union TA…READ FULL ARTICLE
