Regenxbio Shares Up on WSJ Report of FDA U-Turn on Company's Gene Therapy
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 07:19 ET (11:19 GMT)
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