uniQure N.V.
CRL AI-extracted
AMT-130
Huntington’s disease
Date
TBD
FDA decision · Date TBD estimated
What's at stake An FDA complete response letter on AMT-130 for Huntington’s disease is in focus around Date TBD.
“The risk that the FDA ultimately concludes that the Phase I/II trial data are not sufficient to support a BLA or accelerated approval”

Provenance

1 source on file.

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