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REGENXBIO

Regenxbio
Biotech

In another reversal, FDA to reconsider Regenxbio gene therapy

The agency has reversed its previous demand that Regenxbio use an untreated control arm for the one-time Hunter syndrome candidate.
Angus Liu Jun 22, 2026 10:26am
Child jumping on trampoline

Regenxbio reaps pivotal win for Duchenne gene therapy

May 14, 2026 7:25am
step up climb ladder sky hang on rung

Regenxbio gene therapy passes interim test as pivotal data loom

Mar 12, 2026 5:49am
stack of letters mail envelopes

FDA details Regenxbio rare disease rejection

Mar 3, 2026 12:56pm
Image of a neon sign with the word no lit up next to an unlit yes

FDA rejects Regenxbio's Hunter syndrome gene therapy

Feb 9, 2026 4:05pm
Make a delay and accumulation of outstanding tasks Full stop

Brain tumor prompts FDA hold for 2 Regenxbio gene therapies

Jan 28, 2026 9:42am

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