Iryna Drozd
Orchard Therapeutics (NASDAQ:ORTX) stock jumped 13% in afternoon trading Monday after the company said that its Biologics License Application for its drug OTL-200 had been accepted by the FDA under its priority review program, with a decision expected by March 18.
Orchard is seeking to have OTL-200 approved for the treatment of early onset metachromatic leukodystrophy, a rare and often fatal genetic disease. In addition to priority review, the product has also received Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA.
OTL-200 has already been approved by regulators in the EU and UK, where it is marketed under the brand name Libmeldy.
