November 21, 2024

WATCH: RGX-202 – AFFINITY DUCHENNE Pivotal Program and Functional Data (Webinar Recording)

REGENXBIO recently joined PPMD for a community webinar to provide an update on its AFFINITY DUCHENNE trial of RGX-202, REGENXBIO’s microdystrophin gene therapy. Dr. Naz Dastgir discussed the company’s pivotal trial plans and shared interim…

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November 18, 2024

REGENXBIO Initiates Pivotal Phase of AFFINITY DUCHENNE® Trial of RGX-202 Gene Therapy, Reports Positive Functional Data

REGENXBIO Inc. has announced that the AFFINITY DUCHENNE® open-label trial of RGX-202 has advanced to pivotal stage and dosed its first patient. The company also announced new, positive efficacy and safety data from the Phase…

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November 7, 2024

REGENXBIO Shares Updates on Phase I/II AFFINITY DUCHENNE® trial of RGX-202

Yesterday, REGENXBIO shared important updates on their Phase I/II AFFINITY DUCHENNE® trial of RGX-202 for Duchenne during their third quarter financial results update. RGX-202 utilizes a novel adeno-associated virus (AAV8) to transport a shortened version…

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June 24, 2024

REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include New Cohort of Younger Patients

REGENXBIO has announced it initiated enrollment in a new cohort of patients ages 1-3 in its Phase I/II AFFINITY DUCHENNE® trial. The trial is evaluating the safety and efficacy of RGX-202, an investigational gene therapy…

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March 5, 2024

REGENXBIO Shares New Positive Initial Efficacy Data From AFFINITY DUCHENNE Trial

REGENXBIO Inc. has shared an update on the Phase I/II AFFINITY DUCHENNE® trial of RGX-202 in patients with Duchenne ages 4 to 11 years old, including RGX-202 microdystrophin expression from dose level 2. RGX-202 is…

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February 8, 2024

REGENXBIO Announces Completion of Enrollment in Cohort 2 and Additional Positive Interim Data in AFFINITY DUCHENNE® Trial

REGENXBIO Inc. has announced that enrollment has completed at dose level 2 of the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, an investigational gene therapy product for the potential treatment of Duchenne. RGX-202 utilizes a…

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October 4, 2023

REGENXBIO announces interim clinical data from Phase I/II AFFINITY DUCHENNE™ trial of RGX-202

REGENXBIO Inc. has announced additional interim safety data and initial efficacy data from the Phase I/II AFFINITY DUCHENNE™ trial of RGX-202, an investigational gene therapy product for the potential treatment of Duchenne. RGX-202 utilizes a…

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January 24, 2023

REGENXBIO Announces RGX-202 Gene Therapy Trial is Active & Recruiting

REGENXBIO has announced that the Phase I/II AFFINITY DUCHENNE™ trial of RGX-202, an investigational gene therapy product for the potential treatment of Duchenne, is now active and recruiting trial participants. RGX-202 utilizes a novel adeno-associated virus (AAV8)…

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May 4, 2022

Regenxbio Announces Delay in Timeline for Initiation of First Participant Dosed in Affinity Duchenne Trial

REGENXBIO today announced that it will delay the initiation of dosing in the Phase I/II AFFINITY DUCHENNETM trial studying RGX-202 in participants with Duchenne, due to an unexpected observation in the final stages of manufacturing…

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January 6, 2022

REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202 Gene Therapy Candidate for Duchenne

PPMD is excited to share that REGENXBIO has announced that they have received clearance from the FDA on their Investigational New Drug (IND) application for RGX-202, a micro-dystrophin gene therapy product. With this clearance REGENXBIO…

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