Under the Radar: uniQure Shares Surge After FDA's Reversal on Gene Therapy -- WSJ

Dow Jones

06/18

By Xavier Martinez

Shares of biotech uniQure jumped 78% on Wednesday after it said the Food and Drug Administration had reversed itself and agreed to accept data from the company's early-stage trial to support an approval filing for its gene therapy for a rare inherited condition called Huntington's disease.

The FDA first gave Amsterdam-based uniQure the go-ahead to submit its application for approval without running a Phase 3 trial-which is what is typically needed for such a submission-in 2024. The agency reversed course in 2025, citing the same data it had once accepted. By early 2026, it was pushing uniQure toward a new, yearslong trial that would randomly assign patients to the real therapy or a placebo before allowing any filing. Wednesday's reversal, which comes just over a month after the departure of Marty Makary as FDA Commissioner, allows the company to file without that trial.

This item is part of a Wall Street Journal live coverage event. The full stream can be found by searching P/WSJL (WSJ Live Coverage).

(END) Dow Jones Newswires

June 17, 2026 16:48 ET (20:48 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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The full stream can be found by searching P/WSJL (WSJ Live Coverage). \n</p>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  June 17, 2026 16:48 ET (20:48 GMT)\n</p>\n<p>\n  Copyright (c) 2026 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0889565916.HKD","symbol_name":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2644045721","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2644045721","pubTimestamp":1781729280,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Shares of biotech uniQure jumped 78% on Wednesday after it said the Food and Drug Administration had reversed itself and agreed to accept data from the company's early-stage trial to support an approval filing for its gene therapy for a rare inherited condition called Huntington's disease.The FDA first gave Amsterdam-based uniQure the go-ahead to submit its application for approval without running a Phase 3 trial-which is what is typically needed for such a submission-in 2024. 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