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ReAlta's GvHD Therapy Gains EMA Orphan Drug Designation

ReAlta Life Sciences receives EMA Orphan Drug Designation for RLS-0071 treating Graft-versus-Host Disease. Novel peptide therapy shows promise for steroid-refractory patients.

This development matters because Graft-versus-Host Disease represents one of the most serious complications following stem cell transplants, with steroid-refractory cases carrying mortality rates as high as 80%. Current treatments rely heavily on broad immunosuppression that compromises patients' entire immune systems, leaving them vulnerable to infections. Pegtarazimod's targeted approach could revolutionize treatment by specifically addressing the destructive inflammatory pathways while preserving protective immune functions. For transplant patients and their families, this represents hope for more effective treatments with fewer side effects. The EMA designation accelerates development timelines and increases the likelihood that this therapy will reach European patients sooner, potentially saving lives and improving quality of life for those facing this devastating condition.