Plaintiff's law firm issued a press release on February 8, 2019, announcing the filing of the lawsuit. According to the press release, Immunomedics, Inc., a clinical-stage biopharmaceutical company, develops monoclonal antibody-based products for the targeted treatment of cancer. Its advanced antibody-drug conjugates are sacituzumab govitecan and labetuzumab govitecan, which are in advanced trials for various solid tumors and metastatic colorectal cancer, respectively. The company focuses on commercializing sacituzumab govitecan as a third-line therapy for patients with metastatic triple-negative breast cancer in the United States. The company also develops IMMU-140, a humanized antibody directed against an immune response target. Its other product candidates include products for the treatment of cancer and autoimmune diseases, including epratuzumab, an anti-CD22 antibody; veltuzumab, an anti-CD20 antibody; milatuzumab, an anti-CD74 antibody; and IMMU-114, a humanized anti-HLA-DR antibody.
The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors (i) Immunomedics’ Morris Plains, New Jersey drug substance manufacturing facility was not in compliance with U.S. Food and Drug Administration (“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.