UniQure N.V. (NASDAQ:QURE) shares are trading higher Wednesday after the company announced positive topline results from Phase I/II study of AMT-130 in patients with Huntington’s Disease.
What To Know: The study met its primary endpoint, with high-dose AMT-130 showing a statistically significant 75% slowing of disease progression at 36 months as measured by cUHDRS compared to an external control. The therapy also achieved a key secondary endpoint, demonstrating a statistically significant 60% slowing of disease progression as measured by Total Functional Capacity.
Additional measures showed favorable trends, including improvements in motor and cognitive function, and mean CSF NfL levels were below baseline at 36 months. AMT-130 was generally well-tolerated with a manageable safety profile, and UniQure said it plans to submit a BLA in the first quarter of 2026 with a potential U.S. launch later in the year, pending approval.
UniQure also entered into a $175 million non-dilutive senior secured term loan facility with Hercules Capital on Wednesday.
The facility includes three tranches: a first tranche of $50 million refinancing existing debt, a second tranche of $100 million available upon achieving regulatory and financial milestones and a third tranche of up to $25 million subject to Hercules' approval.
UniQure said the transaction enhances financial flexibility and lowers its cost of capital as it prepares for the potential commercial launch of AMT-130.
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QURE Price Action: At the time of writing, UniQure shares are up approximately 234% at $45.63, according to data from Benzinga Pro.
This illustration was generated using artificial intelligence via Midjourney.