regenxbio

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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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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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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November 22, 2021

REGENXBIO Announce Orphan Drug Designation Granted to RGX-202, a Novel Gene Therapy Candidate for Duchenne

PPMD is pleased to share that REGENXBIO Inc. announced this morning that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for RGX-202, a gene therapy approach for the treatment of Duchenne muscular…

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January 5, 2021

REGENXBIO Announces New Gene Therapy Program for Duchenne Muscular Dystrophy

PPMD is incredibly excited to share REGENXBIO’s announcement of their new program for Duchenne muscular dystrophy. REGENXBIO is seeking to treat Duchenne through a gene therapy approach delivering a novel microdystrophin transgene. Their gene therapy…

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