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The Biology Won

The FDA blinks, giving Huntington’s patients hope—and uniQure shareholders a windfall.

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zerohedge.comStai leggendo1 mese fa

The Biology Won

The FDA blinks, giving Huntington’s patients hope—and uniQure shareholders a windfall.

originale

statnews.com

Timeline cronologica

mercoledì 17 giugno 2026·zerohedge.com
The Biology Won
The FDA blinks, giving Huntington’s patients hope—and uniQure shareholders a windfall.
mercoledì 17 giugno 2026·biopharmadive.com
UniQure to file gene therapy for approval, reflecting major shifts at FDA
The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in…

1 mese fa

Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval

The FDA has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker.

Leggi questa versione → originale

biopharmadive.com1 mese fa

UniQure to file gene therapy for approval, reflecting major shifts at FDA

The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.

Leggi questa versione → originale

benzinga.com1 mese fa

FDA Signals uniQure Huntington Gene Therapy Data Could Back Accelerated Approval - uniQure (NASDAQ:QURE)

uniQure stock surged after the FDA said three-year AMT-130 data could support accelerated approval for Huntington's disease treatment.

Leggi questa versione → originale

cnbc.com1 mese fa

UniQure to seek FDA approval for Huntington's disease gene therapy after previous clash with agency

The announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data supporting its application.

Leggi questa versione → originale

endpoints.news1 mese fa

In another reversal, FDA gives uniQure accelerated approval path for Huntington's gene therapy

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.

Leggi questa versione → originale

mercoledì 17 giugno 2026·

statnews.com

Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval

The FDA has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker.

mercoledì 17 giugno 2026·

benzinga.com

FDA Signals uniQure Huntington Gene Therapy Data Could Back Accelerated Approval - uniQure (NASDAQ:QURE)

uniQure stock surged after the FDA said three-year AMT-130 data could support accelerated approval for Huntington's disease treatment.

mercoledì 17 giugno 2026·

endpoints.news

In another reversal, FDA gives uniQure accelerated approval path for Huntington's gene therapy

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.

mercoledì 17 giugno 2026·

cnbc.com

UniQure to seek FDA approval for Huntington's disease gene therapy after previous clash with agency

The announcement comes months after UniQure became embroiled in a public debate with FDA leaders over the clinical trial data supporting its application.