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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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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