By Freddy Sebastian

Shares of Regenxbio gained after the Food and Drug Administration agreed to reverse its rejection of the biotech company's experimental gene therapy for a rare and fatal brain disease.

Regenxbio's stock climbed 12% to $8.75 in premarket trading.

The Wall Street Journal reported Monday that the company plans to refile its application for approval of its Navsunli gene therapy in the third quarter, after it holds a formal meeting to resolve disputes with the FDA that is expected in July.

Regenxbio's Navsunli therapy targets Hunter syndrome, a rare genetic disease that causes irreversible brain damage and cell death, usually leading to death in a patient's midteens, the Journal reported.

The disease affects about 2,000 people worldwide--nearly all boys--and about 50 people are diagnosed a year in the U.S., according to the Journal.

Write to Freddy Sebastian at freddy.sebastian@wsj.com

(END) Dow Jones Newswires

June 22, 2026 07:04 ET (11:04 GMT)

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