RegenxBio Gets FDA Fast-Track Designation for RGX-202 to Treat Duchenne Muscular Dystrophy

By Chris Wack

RegenxBio Inc. said Tuesday that the Food and Drug Administration has granted fast-track designation for RGX-202, a potential one-time gene therapy to treat Duchenne muscular dystrophy.

The designation aims to speed up the development and expedite the review of new therapeutics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs, the Rockville, Md.-based company said.

Therapies granted the fast-track designation have the opportunity for more frequent interactions with the agency and may qualify for priority review, the company said.

The FDA already granted RGX-202 orphan drug designation and rare pediatric disease designation, RegenxBio said.

The company said it plans to report initial data from its clinical trial of RGX-202 in the second half of 2023.

RegenxBio shares were up 5% to $18.13 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

April 11, 2023 07:39 ET (11:39 GMT)

REGENXBIO (NASDAQ:RGNX)
Historical Stock Chart
From Jun 2024 to Jul 2024