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Stock impact report

REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger Patients [Yahoo! Finance]

REGENXBIO Inc. (RGNX) 
Last regenxbio inc. earnings: 2/26 04:05 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.regenxbio.com
Company Research Source: Yahoo! Finance
End-of-Phase II meeting with FDA scheduled for late July to finalize pivotal program design Based on recent commercial landscape, confirmed accelerated approval pathway remains available given ongoing unmet need and RGX-202 differentiated design Remains on track to initiate pivotal trial in late Q3 to early Q4 2024 The next potential therapy to become available for Duchenne patients ROCKVILLE, Md. June 24, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it initiated enrollment in a new cohort of patients ages 1-3 in its Phase I/II AFFINITY DUCHENNE ® trial to evaluate the safety and efficacy of RGX-202 in boys with Duchenne muscular dystrophy (Duchenne). RGX-202 is an investigational one-time AAV Therapeutic targeted to deliver a novel microdystrophin, representing the next wave of innovative design in Duchenne gene therapy. RGX-202 is the only gene therapy approved or in development for Duchenne that incorporates the C-Terminal domain, making the RGX-202 Show less Read more
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