Orchard Therapeutics Up 11% as FDA Gives Priority Review to Biologics License Application

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 [email protected]; @sabelaojeaguix


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