uniQure N.V. is seeking FDA approval for a gene therapy targeting Huntington's disease amid leadership changes impacting the review process.
2 reports, 1 independent
Updated Sep 2
Gone quiet
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What happened
uniQure N.V. is seeking FDA approval for a gene therapy targeting Huntington's disease amid leadership changes impacting the review process.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
- FDA
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Marty Makary
American surgeon and FDA Commissioner
Nothing else this week.
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Vinay Prasad
US hematologist–oncologist
Nothing else this week.
Related events
- FDA placed a clinical hold on a gene therapy involving Hunter.
- Solid Biosciences received FDA approval for a gene therapy trial on July 9, 2025.
- uniQure N.V. traded on the Nasdaq stock exchange and submitted a Biologics License Application (BLA) for accelerated approval of its gene therapy.
- The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.
- A network focused on cell and gene therapies is expanding to include sites in Northern California, involving the CA Institute for Regenerative Medicine and the FDA.