Clinical-stage biopharmaceutical company ReAlta Life Sciences Inc announced on Thursday that the European Medicines Agency (EMA) has granted Orphan Drug Designation to RLS-0071 (pegtarazimod) for the treatment of graft-versus-host disease (GvHD).

This designation follows preliminary data from the company's ongoing Phase 2 trial in steroid-refractory acute GvHD patients.

ReAlta is enrolling patients in an open-label Phase 2 trial across the United States, Germany, and Spain, with additional data expected in 2026. In August 2024, the US Food and Drug Administration also granted Orphan Drug Designation and Fast Track Designation for pegtarazimod in acute GvHD.

The EMA's orphan status is reserved for therapies targeting rare, life-threatening, or chronically debilitating diseases affecting fewer than five in 10,000 people in the EU. Benefits include reduced regulatory fees, protocol assistance, and up to 10 years of market exclusivity upon approval.