Immunomedics, Inc. Loss Form

Company: Immunomedics, Inc.




Lead Plaintiff Deadline: February 25, 2019

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(i) Immunomedics’ Morris Plains, New Jersey drug substance manufacturing facility was not in compliance with FDA requirements; (ii) the Company’s Quality Control Unit did not possess the authority to investigate and correct critical FDA violations occurring at the Morris Plains, New Jersey facility; (iii) the Company suffered a February 2018 data integrity breach at the Morris Plains, New Jersey facility which, among other issues, included the backdating records and manipulation of bioburden samples; (iv) the Company’s Chemistry, Manufacturing and Control data submitted in connection with its BLA for sacituzumab govitecan was insufficient to support FDA approval; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times