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

Dow Jones06-18 04:48

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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