uniQure NV (NASDAQ:QURE) stock has plunged around 31% over the last month, as per data from Benzinga Pro.
• uniQure stock is trading at depressed levels. Where are QURE shares going?
UniQure stock reached as high as $22 on Tuesday before falling during the trading hours. However, there is no news to justify the movement.
In November, the U.S. Food and Drug Administration (FDA) provided feedback to uniQure regarding its investigational gene therapy for Huntington's disease, causing the stock to decline.
uniQure stated that the FDA currently disagrees with the data from the Phase 1/2 studies of AMT-130, in comparison to an external control, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, being adequate to provide primary evidence in support of a BLA submission.
Last week, in the final meeting minutes, and consistent with uniQure's November press release, the FDA conveyed that data submitted from the Phase 1/2 studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission.
In September, uniQure released topline data from the pivotal Phase 1/2 study of AMT-130 for Huntington's disease.
The study met its prespecified primary endpoint, with high-dose AMT-130 demonstrating a statistically significant slowing of disease progression as measured by the composite Unified Huntington's Disease Rating Scale (cUHDRS) at 36 months compared to a propensity score-matched external control.
QURE Price Action: QURE stock was down 0.14% at $20.40 at publication on Tuesday.
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