CytRx Issues Statement Regarding U.S. Regulatory Review of Arimoclomol for Niemann-Pick Disease Type C

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Dec 31, 2020
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CytRx Corporation (OTCQB: CYTR) (“CytRx” or the “Company”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today provided an update on the U.S. Food and Drug Administration’s (“FDA”) review of Orphazyme A/S’s (NASDAQ: ORPH) (“Orphazyme”) New Drug Application (“NDA”) for arimoclomol to treat Niemann-Pick Disease Type C (“NPC”). According to Orphazyme, the FDA has extended the review period with a standard extension of three months in order to complete the NDA review. The updated Prescription Drug User Fee Act (“PDUFA”) target action date is June 17, 2021.