By Karen Roman
ReAlta Life Sciences, Inc. said it was granted Orphan Drug Designation by the European Medicines Agency (EMA) for RLS-0071 (pegtarazimod), to treat Graft-versus-Host Disease (GvHD).
The designation was supported by preliminary data from the company’s Phase 2 trial and follows FDA Orphan Drug and Fast Track designations received in 2024, it stated.
“Receiving EMA Orphan Drug Designation represents a significant new regulatory milestone in our efforts to address the urgent unmet need in aGvHD, and we are particularly encouraged by the EMA’s positive feedback to our initial cohort of Phase 2 data,” said David Marek, ReAlta’s CEO.
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