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Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

Regenxbio plans to resubmit its Hunter syndrome gene therapy RGX-121 after the FDA reversed course, saying existing data are sufficient for accelerated approval review.

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Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

Regenxbio plans to resubmit its Hunter syndrome gene therapy RGX-121 after the FDA reversed course, saying existing data are sufficient for accelerated approval review.

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lunedì 22 giugno 2026·biopharmadive.com
Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection
The agency took another step toward clearing a backlog of Makary-era rejections that appeared to contradict earlier agreements with drugmakers.
lunedì 22 giugno 2026·statnews.com
FDA reverses course on Regenxbio’s childhood gene therapy after rejection
The FDA will reconsider approving Regenxbio's experimental gene therapy for a deadly and rare childhood brain disorder it rejected just four months ago.

Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

Confronto fonti

Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

Timeline cronologica

Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection

FDA reverses course on Regenxbio’s childhood gene therapy after rejection

Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

Confronto fonti

Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

Timeline cronologica

Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection

FDA reverses course on Regenxbio’s childhood gene therapy after rejection

Regenxbio Gains Fresh Chance As FDA Reconsiders Gene Therapy - Regenxbio (NASDAQ:RGNX)

Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection

FDA reverses course on Regenxbio’s childhood gene therapy after rejection

Regenxbio to resubmit Hunter syndrome gene therapy as FDA rare disease about-face continues

Regenxbio Gains Fresh Chance As FDA Reconsiders Gene Therapy - Regenxbio (NASDAQ:RGNX)