Orphazyme Withdraws European Application For Arimoclomol, Initiates Delisting Of Its ADSs

3/22/22 12:23:45 PM ET

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Orphazyme A/S (NASDAQ:ORPH) has decided to withdraw its European Marketing Application for arimoclomol for Niemann-Pick disease Type C (NPC) ahead of a final vote and opinion by the CHMP scheduled for later this month.

"Today's decision to withdraw the MAA enables us to consider the best possible path forward for arimoclomol," commented Orphazyme Chief Executive Officer Anders Vadsholt.
The decision follows CHMP's negative trend vote on arimoclomol application following an Oral Explanation.
Orphazyme is currently under an in-court restructuring and has reduced its workforce by approximately 50% to reduce costs.
As part of the pursuit of a regulatory pathway in the U.S., the Company continues to work towards resubmitting the Company's New Drug Application for arimoclomol to FDA and plans to request a Type C Meeting in Q2 2022.
Orphazyme will voluntarily delist its American Depositary Shares, expected to become effective on March 31.
Price Action: ORPH shares are down 2.94% at $0.82 during the market session on the last check Tuesday.

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