Trial Profile

A pivotal trial of RGX-202

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 23 Aug 2024

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At a glance

Drugs RGX 202-REGENXBIO (Primary)
Indications Duchenne muscular dystrophy
Focus Registrational; Therapeutic Use
Sponsors REGENXBIO

Most Recent Events

01 Aug 2024 According to a REGENXBIO media release, the company recently held a successful End-of-Phase II (EOP2) meeting with the FDA and is moving forward with plans to initiate a pivotal trial in Q4 2024.
08 May 2024 According to a REGENXBIO media release, an end-of-Phase II (EOP2) meeting with FDA in early Q3 2024 is expected to support a final pivotal trial design. Initiation of the pivotal trial is expected in late Q3 2024 to early Q4 2024.
27 Feb 2024 According to REGENXBIO media release, company plans to use RGX-202 microdystrophin expression as a surrogate endpoint to support a Biologics License Application (BLA) filing using the accelerated approval pathway.

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