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.
