Why UniQure Shares Are Plummeting Today?

  • Tucked in its Q2 earnings releaseUniQure N.V. QURE said that in July, it had observed suspected, unexpected severe adverse reactions (SUSARs) in two patients after they were treated with the "higher dose" of AMT-130 in a European Phase 1b/2 trial. 
  • AMT-130 is a gene therapy candidate for Huntington's disease.
  • A third patient treated back in March in the U.S., had their side effect deemed unrelated to the candidate, but it was then reclassified as a severe adverse reaction after review.
  • Related: UniQure Shares Are Up After Low-Dose Cohort Data From Huntington's Gene Therapy Trial.
  • As a result, it's halted dosing in the high-dose cohort. A safety review is ongoing and expected to complete in Q4 of 2022
  • The DSMB does not view these findings as dose-limiting toxicity, and no clear root cause has yet been identified.
  • The company added that they are considering potential risk mitigation plans over the next 2-3 months.
  • The patients were hospitalized, with the U.S. patient suffering a severe headache. 
  • The company held cash and cash equivalents of $500.5 million, sufficient to fund operations into 1H of 2025.
  • Price Action: QURE shares are down 31.1% at $17.61 during the market session on the last check Monday.
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