The Manila Times·3 min read·medium
TolerogenixX Has Received EMA Orphan Drug Designation for MIC-Lx, Strengthening its Regulatory Pathway in Kidney Transplantation
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TolerogenixX has received Orphan Drug Designation from the EMA for its kidney transplant therapy, MIC-Lx. This follows a previous PRIME designation, marking a significant step toward regulatory approval for a treatment designed to reduce reliance on systemic immunosuppression.
The Orphan Drug Designation follows the recent granting of EMA PRIME designation for MIC-Lx, marking a second key regulatory milestone and further strengthening the Company's pathway toward full regulatory approval.
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