US FDA to reverse rejection of Regenxbio's rare-disease drug, WSJ reports

The U.S. Food and Drug Administration will reverse its rejection of Regenxbio's 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 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 could not immediately be reached for comment outside regular business hours.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Diti Pujara)

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This story was originally published June 22, 2026 at 6:10 AM.