REGENXBIO

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Biotech

FDA details Regenxbio rare disease rejection

The agency's rationale should have little impact on Denali Therapeutics, which is awaiting a decision on its own Hunter syndrome candidate.
Darren Incorvaia Mar 3, 2026 12:56pm
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FDA rejects Regenxbio's Hunter syndrome gene therapy

Feb 9, 2026 4:05pm
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Brain tumor prompts FDA hold for 2 Regenxbio gene therapies

Jan 28, 2026 9:42am
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Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am
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RegenXBio links DMD gene therapy to improved outcomes

Jun 5, 2025 8:52am
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RegenXBio sells $250M of paydays for Zolgensma, other therapies

May 20, 2025 7:15am