UniQure falls after FDA commissioner comments

uniQure

26/02/2026 20:15

** U.S.-listed shares of Dutch firm UniQure UQ1.F, QURE.O fall 33.2% to $16.57

** Shares of the co fall after U.S. FDA Commissioner Marty Makary's CNBC appearance on rare disease therapy approvals

** Makary's comments on CNBC described rejecting an unnamed drug involving drilling into patients' skulls that showed no benefit in trials

** Co is developing a gene therapy, AMT-130, for Huntington’s disease, a rare condition that affects motor function; its therapy is delivered directly to the brain by inserting a micro‑catheter to the brain

** "The Commissioner's comments (specifically referencing researchers drilling holes in patients' skulls) appear directed at QURE's gene therapy approach for HD"- RBC Capital Markets

** The Commissioner's comments are clearly disappointing as the Agency appears less open-minded on a path forward for HD - RBC analysts

** Last month, UniQure scheduled a Type A FDA meeting to advance its Huntington's therapy, after the regulator said the trial data might be insufficient for a marketing application

** UniQure did not immediately respond to Reuters' request for comment

** UniQure rose 35.5% in 2025

 (Reporting by Sneha S K and Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com;))