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AMT-130

Coverage of AMT-130 in the Nexus archive.

Earliest in view: Jun 17 · 11:43 UTCMost recent: Jun 17 · 11:43 UTC
Co-mentioned in this coverage
UniQureorganization1Food and Drug Administrationorganization1Marty Makaryperson1Vinay Prasadperson1Huntington’s diseasetopic1
Recent coverage
  • HEALTHJun 17 · 11:43 UTCSTAT NEWS
    STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval

    The FDA has reversed its opposition to UniQure's experimental Huntington’s disease treatment AMT-130, allowing the company to file for U.S. approval. UniQure plans to submit a marketing application in Q3 for accelerated approval, citing a three-year analysis of early-stage study data as acceptable to the FDA, despite previous objections from former agency officials.