CYTR - CytRx announces FDA extension of review for rare disease therapy

CytRx Corporation ([[CYTR]] -5.4%) announces that the FDA has extended the review period for its New Drug Application for arimoclomol to treat Niemann-Pick Disease Type C (“NPC”) by three months. The updated PDUFA target action date is June 17, 2021.Despite the delay, NDA will remain under the Priority Review of FDA, and the company’s eligibility for a Pediatric Rare Disease Priority Review Voucher remains, a statement CytRx said.If approved in the U.S., arimoclomol will be the first and only approved medicine for NPC, a rare, genetic, and progressive disease, causing lipid accumulation within the body’s tissue, including the brain.In 2011, CytRx sold the rights for arimoclomol to Orphazyme A/S (ORPH) (formerly Orphazyme ApS) in exchange for a one-time upfront payment, milestone payments worth $120M, and royalties.

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CytRx announces FDA extension of review for rare disease therapy