Benzinga | Oct 23, 2020 08:28AM EDT

Orphazyme Accelerates Arimoclomol Pre-launch Activities And Updates Financial Outlook For 2020; Updates FY20 Operating Loss Guidance From $80M-$88M To $96M-$104M

Copenhagen, Denmark, October 23, 2020 -- Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein (HSP) response for the treatment of neurodegenerative orphan diseases, today announces an update to its financial outlook for 2020. The update is primarily driven by an acceleration in commercial and other pre-launch activities during the fourth quarter of 2020 in preparation for potential approval of its investigational product candidate arimoclomol in Niemann-Pick disease Type C (NPC), which is currently under Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of March 17, 2021.

The increased expenditure is based on Orphazyme's reinforced financial position following a successful global offering, as well as the FDA acceptance of its New Drug Application (NDA) for arimoclomol for NPC and granting of Priority Review. The Company also plans additional investments to further develop its pipeline.