By Sabela Ojea

Shares of Orchard Therapeutics on Monday climbed after the company said the U.S. Food and Drug Administration accepted the filing of its biologics license application to treat a rare disease called metachromatic leukodystrophy under priority review.

At 14:18 pm E.T., shares were up 11% at $5.75. The stock has jumped 55% since the year started and increased 23% in the past 12 months.

The gene therapy biotechnology company said the FDA's approval relates to its OTL-200 treatment, which previously received both rare pediatric disease and regenerative medicine advanced therapy designations from the FDA.

"We are working diligently in parallel to prepare for a potential launch in 2024 and ensure OTL-200 will be available to patients in the U.S. as quickly as possible," Chief Executive Bobby Gaspar said.

Metachromatic leukodystrophy is a rare hereditary disease that damages the central nervous system.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

September 18, 2023 14:59 ET (18:59 GMT)