Orphazyme A/S (NASDAQ:ORPH) has been notified by the Committee for Medicinal Products for Human Use (CHMP) of a negative trend vote on arimoclomol application following an Oral Explanation.
- The application covers arimoclomol for Niemann-Pick disease type C (NPC), a rare genetic disorder characterized by an inability of the body to transport cholesterol and other fatty substances (lipids) inside of cells.
- The Company said that it was encouraged by the ad-hoc expert group meeting's positive feedback on February 17, 2022.
- Related: Orphazyme Tightens FY21 Revenue Outlook.
- But the trend vote indicates that the CHMP's current orientation is to not approve arimoclomol when it convenes by the end of March 2022.
- Orphazyme considers it unlikely to change this position before the formal vote is undertaken next month.
- In the light of the recent development and the Company's financial situation, the Company will now assess the Company's strategic options and provide an update.
- Price Action: ORPH shares are down 28.7% at $1.44 during the premarket session on the last check Thursday.
