UniQure Wins FDA Path to Q3 Huntington's Filing Without New Trial
Updated
Updated · Bloomberg · Jun 17
UniQure Wins FDA Path to Q3 Huntington's Filing Without New Trial
3 articles · Updated · Bloomberg · Jun 17
Summary
Q3 2026 is UniQure's target for a US approval filing after the FDA said existing AMT-130 study data can support an expedited application.
The reversal lets UniQure skip a new Huntington's disease trial, a major shift from the agency's earlier demand for additional study work.
UniQure shares soared on the news, underscoring investor relief that the gene therapy now has a clearer route toward potential US approval.
The decision follows the FDA's earlier overturning of a rejection tied to former Trump official Vinay Prasad, signaling a softer stance on some drug reviews.