Orchard: Application for OTL-200 in MLD, Receives Priority Review

 PDUFA date set for March 18, 2024

OTL-200 would be the first and only treatment in the U.S. for early-onset metachromatic leukodystrophy (MLD)

Previously published data demonstrated administration of one-time gene therapy enables sustained preservation of motor function and cognitive development

https://finance.yahoo.com/news/orchard-therapeutics-announces-acceptance-biologics-110000054.html