REGENXBIO

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Biotech

Regenxbio gene therapy refiling plan derailed by FDA hold

The FDA put a hold on RGX-121 over spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy.
Nick Paul Taylor Aug 24, 2026 7:51am
Regenxbio

In another reversal, FDA to reconsider Regenxbio gene therapy

Jun 22, 2026 10:26am
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Regenxbio reaps pivotal win for Duchenne gene therapy

May 14, 2026 7:25am
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Regenxbio gene therapy passes interim test as pivotal data loom

Mar 12, 2026 5:49am
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FDA details Regenxbio rare disease rejection

Mar 3, 2026 12:56pm
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FDA rejects Regenxbio's Hunter syndrome gene therapy

Feb 9, 2026 4:05pm