UniQure (QURE) Soars 78% on AMT-130 Progress

UniQure NV (NASDAQ:QURE) is one of the 10 Stocks Making Investors Richer.

UniQure skyrocketed by 78.44 percent on Wednesday to finish at $48.16 apiece as investors gobbled up shares after the Food and Drug Administration (FDA) approved the analyses from its AMT-130 clinical study, paving the way for the submission of a biologics license application (BLA).

In an updated report, UniQure NV (NASDAQ:QURE) said that the FDA officially accepted data analysis from the first phase of the clinical trial, walking back its earlier requirement to submit additional data.

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However, the agency is requiring an alignment meeting with the listed firm to discuss a confirmatory study design before the BLA, including consideration of concurrent control on standard-of-care therapy instead of a sham procedure.

UniQure NV (NASDAQ:QURE) intends to submit the BLA in the third quarter of the year.

“The FDA has agreed that our current clinical data can support a near-term BLA submission and has committed to working expeditiously with us to align on the design of the required confirmatory study. The consistency and strength of the clinical data generated to date give us great confidence in the product’s potential to make a meaningful difference for patients. We remain focused on bringing AMT-130 to patients and families as quickly and responsibly as possible in the US and globally,” UniQure NV (NASDAQ:QURE) CEO Matt Kapusta said.

AMT-130 has been granted a Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA—the first one to be designated for Huntington’s disease. It also secured a breakthrough therapy and fast-track designation.

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