AnnJi Pharmaceutical Advances AJ201 into Pivotal Phase 3 ROMA-KD Trial for Spinal and Bulbar Muscular Atrophy (SBMA)

What happened: AnnJi Pharmaceutical said it is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial of AJ201 (rosolutamide) in patients with spinal and bulbar muscular atrophy (SBMA, or Kennedy's disease), following submission of the Phase 3 protocol to the U.S. Why it matters: The company describes AJ201 as the only known investigational therapy for SBMA in Phase 3 development worldwide. It holds FDA Fast Track Designation and Orphan Drug Designation in the U.S. and EU, and the trial is intended to support potential global regulatory submissions.

AnnJi Pharmaceutical said it is proceeding with the U.S. portion of its pivotal Phase 3 ROMA-KD trial of AJ201 (rosolutamide) in patients with spinal and bulbar muscular atrophy (SBMA, or Kennedy's disease), following submission of the Phase 3 protocol to the U.S.

The company describes AJ201 as the only known investigational therapy for SBMA in Phase 3 development worldwide. It holds FDA Fast Track Designation and Orphan Drug Designation in the U.S. and EU, and the trial is intended to support potential global regulatory submissions.