- Company Name
- Immunomedics, Inc.
- Stock Symbol
- Class Period
- August 23, 2018 to December 20, 2018
- Motion Deadline
- February 25, 2019
- District of New Jersey
The complaint charges Immunomedics and certain of its officers with violations of the Securities Exchange Act of 1934. Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer.
The complaint alleges that defendants made false and misleading statements and/or failed to disclose material adverse facts regarding Immunomedics’ business and operations. Specifically, the complaint alleges that defendants misled investors by failing to disclose in SEC filings during the Class Period that the FDA had cited the Company for a host of violations observed at its Morris Plains, New Jersey, drug substance manufacturing facility, including violations for manipulating bioburden samples, misrepresenting an integrity test procedure in the batch record, and backdating batch records, including the dates of analytical results. As a result of this information being withheld from the market, the price of Immunomedics stock was artificially inflated to more than $26 per share during the Class Period.
On December 17, 2018, FDAnews.com published an article disclosing that the FDA had charged Immunomedics with a data integrity breach, citing “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 article stated that the breach included “manipulated bioburden samples, misrepresentation of an integrity test procedure in the batch record, and backdating of batch records, such as dates of analytical results.” On this news, the price of Immunomedics stock fell 4%. Then on December 20, 2018, Favus Institutional Research issued a report discussing the data integrity breach. On the issuance of the Favus report, the price of Immunomedics stock dropped nearly 20%, from a close of $17.64 per share on December 19, 2018 to a close of $14.17 per share on December 20, 2018.