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Immunomedics receives CRL for sacituzumab govitecan

  • Immunomedics (NASDAQ:IMMU) has received a Complete Response Letter (CRL) from the FDA for its BLA seeking accelerated approval for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
  • The Company will host a conference call today at 8:00 am ET to discuss the rejection.
  • Shares, currently halted, will resume trading at 9:10 am ET.
  • Update: Shares are down 35% premarket.

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