Hunter syndrome

stack of letters mail envelopes

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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Royalty's $275M financing deal for Denali drug awaiting FDA nod

Dec 4, 2025 10:20am

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Denali's Hunter syndrome drug latest to be hit by FDA delay

Oct 14, 2025 8:09am

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Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am

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Denali rare disease drug clears safety study, reduces biomarkers

Feb 6, 2025 12:05pm