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Investigations  /  01.04.2019

Immunomedics, Inc.

Immunomedics, Inc. (IMMU) Accused of Data Integrity Breach

According to the complaint against the company for alleged violations of the Securities and Exchange Act of 1934 between August 23, 2018 and December 20, 2018, on December 17, 2018, FDAnews.com published an article, stating that “[t]he FDA cited Immunomedics for a host of violations – including its handling of a data integrity breach – observed at its Morris Plains, New Jersey, drug substance manufacturing facility between August 6 and 14.” The breach purportedly included “manipulated bioburden samples, misrepresentations of in integrity test procedure in the batch record, and backdating of batch records, such as dates of analytical results.” On December 20, 2018, Favus Institutional Research issued its own report discussing the data integrity breach. On this news, Immunomedics’s stock fell 20% to close at $14.17 on December 20, 2018.

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