Penn spinout REGENXBIO received FDA Fast Track designation for its novel gene therapy candidate RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne muscular dystrophy (Duchenne).
“Fast Track designation, along with our capabilities to conduct our clinical trials using commercial-scale cGMP material, will further support the efficient development of RGX-202 from clinic to commercial readiness,” said Kenneth Mills, President, and CEO of REGENXBIO, according to PR Newswire.