Latest News for: rgx

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REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II

Citizen Tribune 19 Aug 2025
RGX-121 would be the first and only potential one-time ...
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RGX-121 (clemidsogene lanparvovec) : Regarding the extension of the U.S. FDA review period (Nippon Shinyaku Co Ltd)

Public Technologies 19 Aug 2025
Food and Drug Administration (FDA) extended its review timeline of the Biologics License Application (BLA) for RGX-121 (clemidsogene lanparvovec) for the treatment of Mucopolysaccharidosis II (MPS II).
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REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II (Form 8-K) (Regenxbio Inc)

Public Technologies 18 Aug 2025
Food and Drug Administration (FDA) extended its review timeline of the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.
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REGENXBIO Announces Publication of Preclinical Results Demonstrating Functional Benefits of Novel Microdystrophin Construct in RGX-202 Investigational Gene Therapy for Duchenne Muscular Dystrophy

PR Newswire 10 Jul 2025
REGENXBIO is enrolling participants in the pivotal portion of the Phase I/II/III AFFINITY DUCHENNE trial of RGX-202 and expects to submit a Biologics License Application (BLA) using the accelerated approval pathway in mid-2026. .
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REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202

Victoria Advocate 05 Jun 2025
RGX-202 demonstrating consistent evidence of positively changing ...
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REGENXBIO to Host Webcast Discussing Interim Functional Data from the Phase I/II AFFINITY DUCHENNE® Trial of RGX-202

PR Newswire 02 Jun 2025
... trial of RGX-202, the company's next-generation investigational gene therapy for the treatment of Duchenne muscular dystrophy ... Webcast detailsTitle. AFFINITY DUCHENNE® Trial of RGX-202.
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