Brief: Uniqure Announces Alignment With FDA On Accelerated Approval Pathway For AMT-130 In Huntington’S Disease
10/12/2024 12:54
Dec 10 (Reuters) - Uniqure UQ1.F :
* UNIQURE ANNOUNCES ALIGNMENT WITH FDA ON KEY ELEMENTS OF
ACCELERATED APPROVAL PATHWAY FOR AMT-130 IN HUNTINGTON’S DISEASE
* UNIQURE NV - FDA AGREES CUHDRS MAY SERVE AS INTERMEDIATE
CLINICAL ENDPOINT
* UNIQURE NV - FDA AGREES PHASE I/II DATA MAY SERVE AS BASIS
FOR
BLA
* UNIQURE NV - FDA AGREES NO ADDITIONAL PRE-SUBMISSION STUDY
NEEDED FOR AMT-130
Source text: ID:nGNXXSS7S
Further company coverage: UQ1.F
((Reuters.Briefs@thomsonreuters.com;))
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