The FDA has reversed course and allowed uniQure to seek accelerated approval for the Huntington's gene therapy AMT-130 after Prasad and Makary's departures.
June 17, 2026 11:40 AM EDTUpdated 02:01 PM
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In another reversal, FDA gives uniQure accelerated approval path for Huntington's gene therapy
Max Gelman
Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad.
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The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts…
uniQure stock surged after the FDA said three-year AMT-130 data could support accelerated approval for Huntington's disease…
The FDA has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its…
The announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data…
UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA…
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