The European Medicines Agency (EMA) has validated Orchard Therapeutics’ (NASDAQ:ORTX) Marketing Authorization Application for OTL-200, an ex vivo, autologous, hematopoietic stem cell-based gene therapy that has been developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy, for the treatment of metachromatic leukodystrophy (MLD).
Validation confirms that the submission is sufficiently complete to begin the formal review process.
Shares are up 2% premarket.
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