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US FDA to reverse rejection of Regenxbio's rare-disease drug, WSJ reports
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US FDA to reverse rejection of Regenxbio's rare-disease drug, WSJ reports
Jun 22, 2026 4:35 AM

June 22 (Reuters) - The U.S. Food and Drug Administration

will reverse its rejection of Regenxbio's ( RGNX ) rare-disease

gene therapy, Navsunli, as the drug developer works to resubmit

its application, the Wall Street Journal reported on Monday.

Shares of the drug developer were up 11% in premarket

trading.

Regenxbio ( RGNX ) will refile its application in the third quarter,

following a formal meeting with the agency expected in July, the

report said, citing CEO Curran Simpson.

In February, the FDA declined to approve Navsunli for Hunter

syndrome, citing uncertainty over the trial design.

Regenxbio ( RGNX ) could not immediately be reached for comment

outside regular business hours.

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