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"Truly evil" FDA rejection of gene therapy overturned after Trump official ousted

The FDA reversed its previous rejection of UniQure's AMT-130 gene therapy for Huntington's disease. The agency no longer requires sham-surgery controls for clinical trials. This change follows the removal of Trump-era officials.

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What changed

The update clarifies that the FDA has specifically reopened the approval pathway for the one-time therapy.

Live updates

  1. FDA Reopens Approval Pathway for UniQure Huntington's Therapy

    The FDA reversed its previous rejection of UniQure's AMT-130 gene therapy for Huntington's disease. The agency no longer requires sham-surgery controls for clinical trials. This change follows the removal of Trump-era officials.

    What's confirmed:

    • The FDA overturned its rejection of UniQure's AMT-130 gene therapy for Huntington's disease.
    • The FDA now permits standard-care comparators instead of requiring sham brain surgery for clinical trial controls.
    • UniQure is a Dutch biopharmaceutical company that develops adeno-associated virus gene therapies.
    • The FDA approved UniQure's Hemgenix for haemophilia B in 2022.
    • UniQure's alipogene tiparvovec received approval in 2012 but left the market in 2017.

    Still unconfirmed:

    • The reversal of regulatory demands followed the removal of Trump-era officials including Vinay Prasad.
    • The erasure of former FDA leaders is continuing.
    confidence 90%

  2. FDA Reverses Rejection of UniQure Huntington's Gene Therapy

    The FDA overturned its previous rejection of UniQure's AMT-130 gene therapy for Huntington's disease. This reversal follows the removal of Trump-era officials, including Vinay Prasad. The agency now allows the use of standard-care comparators instead of requiring sham brain surgery for clinical trial controls.

    What's confirmed:

    • The FDA reversed its previous rejection of uniQure's AMT-130 gene therapy for Huntington's disease.
    • The reversal allows uniQure to seek approval for the treatment.

    Still unconfirmed:

    • The FDA previously demanded that patients undergo sham brain surgery as clinical trial controls.
    confidence 80%

  3. FDA Reverses Rejection of UniQure Huntington's Gene Therapy

    The FDA has reversed a previous rejection of uniQure's Huntington's disease gene therapy, AMT-130. This shift allows the company to seek approval for the treatment. UniQure shares surged following the news.

    What's confirmed:

    • UniQure is now cleared to submit its Huntington's disease gene therapy, AMT-130, for FDA approval.
    • UniQure stock surged after the FDA reversal.
    • The FDA previously clashed with uniQure over the therapy.

    Still unconfirmed:

    • The reversal occurred after the ouster of Trump officials including Vinay Prasad.
    • One source described the previous FDA rejection as truly evil.
    • UniQure stock surged 81%.
    • UniQure stock soared 78%.
    confidence 90%