uniQure Receives FDA Priority Review for AMT-130 with PDUFA Date Set for May 2027
uniQure N.V. (QURE) has reached a significant regulatory milestone as the FDA accepted its Biologics License Application (BLA) for AMT-130. The agency has granted priority review for the therapy, establishing a target PDUFA action date of May 1, 2027. In addition to the regulatory progress, the company is outlining a confirmatory study involving approximately 200 patients. This development marks a critical step in uniQure's efforts to bring its gene therapy candidate to market and provides a clear timeline for potential commercialization.
Tickers: $QURE
Topics: AMT-130 Biologics License Application Earnings Call FDA Priority Review
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Part of the story UniQure outlines AMT-130 confirmatory study of ~200 patients with May 1, 2027 PDUFA date in focus (2 articles)