08:58 AM EDT, 05/13/2025 (MT Newswires) -- Regenxbio ( RGNX ) said Tuesday that the US Food and Drug Administration has accepted and granted priority review to a biologics license application for clemidsogene lanparvovec, or RGX-121, to potentially treat mucopolysaccharidosis II, also known as Hunter syndrome.

The FDA has set a target action date of Nov. 9, the company said.

The drug earlier received orphan drug product, rare pediatric disease, fast track, and regenerative medicine advanced therapy designations from the FDA as well as an advanced therapy medicinal products classification from the European Medicines Agency, Regenxbio ( RGNX ) said.

Hunter syndrome is a rare genetic disease which can lead to severe developmental delays in children.

Shares of Regenxbio ( RGNX ) were up more than 6% in recent premarket activity.