Orchard Therapeutics provides FY23 key milestones

Orchard Therapeutics announced recent commercial and regulatory accomplishments and outlined key 2023 milestones. Key 2023 Priorities: Orchard has outlined the following key milestones expected for 2023: Libmeldy: Secure reimbursement agreements in at least two additional markets in Europe and establish qualified treatment centers in Sweden, Spain and Saudi Arabia. Expand newborn screening activities throughout Europe, the U.S. and the Middle East. OTL-200 for metachromatic leukodystrophy: Conduct a clinical Type B meeting with the U.S. Food and Drug Administration in early 2023 in advance of an anticipated BLA submission. OTL-203 for mucopolysaccharidosis type I Hurler’s: Initiate a global, registrational trial in the second half of 2023. OTL-201 for mucopolysaccharidosis type IIIA: Report additional biochemical and clinical data from the ongoing proof-of-concept study. OTL-104 for NOD2-Crohn’s disease: Report pre-clinical PoC data in the first half of 2023 and initiate IND-enabling activities in advance of a planned 2024 filing. Advance the company’s other preclinical programs, which includes a program partnered with and funded by Pharming in hereditary angioedema, OTL-105.