Orchard Therapeutics Announces U.S. FDA Clearance of IND Application for OTL-203 in MPS-IH

January 5, 2023

https://www.globenewswire.com/news-release/2023/01/05/2583531/0/en/Orchard-Therapeutics-Announces-U-S-FDA-Clearance-of-IND-Application-for-OTL-203-in-MPS-IH.html

BOSTON and LONDON, Jan. 05, 2023 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq:ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OTL-203, a hematopoietic stem cell (HSC) gene therapy being developed for the treatment of the Hurler subtype of mucopolysaccharidosis type I (MPS-IH). The company expects to initiate a global registrational trial evaluating the efficacy and safety of OTL-203 compared to standard of care in the second half of 2023.

Read more at globenewswire.com

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