BioPharma Dive December 10, 2024
The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an “accelerated approval” application.
Shares of UniQure doubled Tuesday morning after the Netherlands-based biotechnology company trumpeted that its experimental treatment for Huntington’s disease could be eligible for a speedy kind of approval.
Known as AMT-130, the treatment is one of UniQure’s most advanced and closely watched assets. It’s a gene therapy designed to enter brain cells and block the genetic instructions for the protein that causes Huntington’s. UniQure has been periodically providing updates from two clinical trials testing multiple doses of AMT-130, and in July said the therapy appears to be slowing the progression of Huntington’s in patients who...
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