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FDA主要官员离职后，uniQure激增
2026-03-09 21:01
- Despite a US FDA official criticizing uniQure (QURE) on March 5 for the way it conducted a study for Huntington's disease asset AMT-130, the stock is surging ~36% in premarket trading Monday.
- That official, in a call with reporters, accused uniQure of "performing a distorted or manipulated comparison" in its phase 1/2 trial, which it had intended to use for its application with the FDA. The agency has requested the company conduct a phase 3 trial.
- However, since the official's comments, uniQure's share price has fared well, closing up ~18% on March 5. It added another ~34% on March 6.
- UniQure's fortune likely changed for the better due to the announcement on March 6 that Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), will be departing the agency in April. Prasad oversaw the agency's handling of AMT-130.
More on uniQure
- uniQure: Worst Case Scenario Becomes Reality
- uniQure: The Worst Case Scenario Just Got Official (Rating Downgrade)
- uniQure N.V. (QURE) Q4 2025 Earnings Call Transcript
- uniQure used 'distorted comparison' in Huntington's asset trial: FDA official
- uniQure plummets as FDA calls for phase 3 trial for Huntington's asset AMT-130
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