Regulatory Daily Summary
Regulatory Daily Summary: What Happened on November 8, 2026
FDA grants priority review to uniQure’s Huntington’s gene-therapy application
A Senate discussion draft would also change how the FDA reviews software-based and integrated medical devices.
Today in brief
The FDA accepted uniQure’s application for AMT-130, its Huntington’s disease gene therapy, and granted it priority review.1 Senator Bill Cassidy announced a discussion draft proposing new FDA review options for software-based and integrated medical devices.2
Also worth knowing
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AMT-130 uses an AAV5 vector to deliver an artificial microRNA designed to silence the Huntingtin gene. Treatment requires neurosurgery, and neuroinflammation occurred in some patients.1
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The draft would allow voluntary preliminary review of device components, establish risk-based review for software devices and create an accredited third-party review program. Its authors say the proposals’ practical value will depend on implementation.2