Drug Profile

RGX 202- REGENXBIO

Alternative Names: RGX-202 - REGENXBIO

Latest Information Update: 26 Mar 2026

Price :

$50 ^*

Note:

Adis is an information provider. We do not sell or distribute actual drugs.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
A link to download a PDF version of the drug profile will be included in your email receipt.

At a glance

Originator REGENXBIO
Class Gene therapies
Mechanism of Action Dystrophin replacements; Gene transference

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Duchenne muscular dystrophy
New Molecular Entity No

Highest Development Phases

Phase II/III Duchenne muscular dystrophy

Most Recent Events

11 Mar 2026 REGENXBIO announces its intention to request a pre-BLA meeting with the US FDA for Duchenne muscular dystrophy in mid-2026
11 Mar 2026 Efficacy, pharmacodynamics and adverse events data from the phase I/II AFFINITY DUCHENNE trial in Duchenne muscular dystrophy released by REGENXBIO
11 Jan 2026 FDA assigns PDUFA action date of 31/12/2026 for RGX 202 for Duchenne muscular dystrophy

You need to be a logged in or subscribed to view this content

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com