Orphazyme (ORPH) has received CRL from the FDA following its review of the new drug application for arimoclomol
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Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C
June 18, 2021 1:00 AM EDTOrphazyme A/SCompany announcement        No. 16/2021Inside informationCompany Registration No. 32266355
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Copenhagen June 18, 2021 Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C (NPC).
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