uniQure Wins FDA Clearance of Investigational New Drug Application for AMT-260 Gene Therapy for Refractory Mesial Temporal Lobe Epilepsy
Portfolio Pulse from Benzinga Newsdesk
uniQure N.V. (NASDAQ:QURE) has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for AMT-260, a gene therapy candidate for refractory mesial temporal lobe epilepsy (MTLE). AMT-260 uses an AAV9 vector to deliver two engineered miRNAs designed to degrade the GRIK2 gene and suppress the aberrant expression of glutamate receptor subtype GLUK2, which is believed to trigger seizures in patients with refractory MTLE.
September 05, 2023 | 11:06 am
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The FDA clearance of uniQure's IND application for AMT-260 could potentially boost the company's stock as it signifies regulatory progress and potential market expansion for the company's gene therapy portfolio.
The FDA clearance of the IND application for AMT-260 signifies regulatory progress for uniQure. This could potentially lead to market expansion for the company's gene therapy portfolio, which could positively impact the company's stock in the short term.
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