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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