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Zevra股价在FDA关于阿尼莫的会议前上涨16%

2024-08-01 02:49

  • Shares of Zevra (NASDAQ:ZVRA) climbed 16% Wednesday ahead of an FDA advisory committee meeting on Friday that will discuss the company’s resubmitted market application for arimoclomol.
  • The Danish company is seeking to have the product approved for the treatment of adults and pediatric patients two years of age or older with Niemann-Pick disease type C.
  • Zevra (ZVRA) resubmitted the application in December 2023. The FDA declined to approve the product in June 2021, issuing a Complete Response Letter to the product’s former owner, Orphazyme. Zevra (ZVRAacquired arimoclomol in May 2022.
  • The FDA is expected to issue a decision on whether to approve the therapy by Sept. 21.
  • Zevra (ZVRA) was formerly known as KemPharm. 

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