The FDA decision on OTL-200 in the proposed indication of metachromatic leukodystrophy, a rare and life-threatening inherited disease of the body’s metabolic system, is anticipated on March 18, 2024.OTL-200 is approved by the European Commission (EC) and UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of eligible patients with early-onset metachromatic leukodystrophy and is marketed under the brand name Libmeldy.OTL-200/Libmeldy was developed by Orchard Therapeutics, which was acquired by Japan-based Kyowa Kirin Co., Ltd. (KYKOF.PK) earlier this year.KYKOF.PK closed Tuesday's (Feb.27, 2024) trading at $16.02.