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UniQure outlines planned BLA submission for AMT-130 in Q1 2026 amid regulatory alignment and pipeline momentum
Management reiterated the expectation for top line pivotal data from AMT-130 and initial Fabry data in September, with a planned BLA submission for AMT-130 in the first quarter of 2026. The team ...
~ U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License ...
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