NEW YORK, NY / ACCESSWIRE / February 24, 2019 / Pomerantz LLP announces that a class action lawsuit has been filed against Immunomedics, Inc. ("Immunomedics" or the "Company") (IMMU) and certain of its officers and directors. The class action, filed in United States District Court, District of New Jersey, and indexed under 19-cv-05151, is on behalf of a class consisting of all behalf of persons and/or entities who purchased or otherwise, acquired Immunomedics securities between February 8, 2018 and January 18, 2019, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials
If you are a shareholder who purchased Immunomedics securities between February 8, 2018, and January 18, 2019, you have until February 25, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
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.
On December 17, 2018, the FDAnews.com published an article titled "FDA Hits Immunomedics for Data Integrity Breach." According to this article, "[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 article states that this 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 December 17, 2018, following the publication of the FDAnews.com story, Immunomedics shares fell from an opening price of $18.54 to close at $17.86, a decline of 4%.
On December 20, 2018, the truth was fully revealed to the market when Favus Institutional Research issued a Report (the "Favus Report") providing additional details regarding the data integrity breach.
Following the Favus Report, the Company's stock price fell drastically, from $17.64 at close on December 19, 2018, to $14.17 at close on December 20, 2018, a drop of 20%.
Then on January 17, 2019, the Company announced that it "received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking accelerated approval of 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." In the CRL, the FDA raised issues related to approvability "focused on Chemistry, Manufacturing and Control matters."
Following the news of the CRL, the Company's stock price fell drastically, from $18.09 at close on January 17, 2019, to $13.31 at close on January 18, 2019, a drop of approximately 26%.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
SOURCE: Pomerantz LLP
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