Immunomedics investors may receive additional information about the case by clicking the link "Submit Your Information" above.
The first complaint was filed on December 27, 2018 in the District of New Jersey against Immunomedics on behalf of purchasers of Immunomedics common stock between August 23, 2018 and December 20, 2018.
On February 8, 2019, a second complaint (the “Second Complaint”) was filed in the same court and expanded the class period to include purchasers of Immunomedics common stock between February 8, 2018 and January 18, 2019.
According to the Second Complaint, the Class Period commences on February 8, 2018, when Immunomedics filed its Form 10-Q with the SEC for the quarterly period ended December 31, 2017.
According to the Second Complaint, on December 17, 2018, the truth was partially revealed when 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 stated 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.” Following the publication of the FDAnews.com article, Immunomedics’ shares fell from an opening price of $18.54 to close at $17.86, a decline of 4%.
Then, on December 20, 2018, Favus Institutional Research issued a report (the “Favus Report”) discussing the data integrity breach. Following the Favus Report, Immunomedics’ stock price fell from $17.64 at close on December 19, 2018 to $14.17 at close on December 20, 2018, a drop of 20%.
Finally, on January 17, 2019, Immunomedics 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, Immunomedics’ 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%.
If you are a member of the class described above, you may no later than February 25, 2019 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-888-299-7706 or 1-610-667-7706, or via e-mail at firstname.lastname@example.org. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.
Kessler Topaz Meltzer & Check, LLP
James Maro, Esq. or Adrienne Bell, Esq.
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Radnor, PA 19087
1-888-299-7706 (toll free) or 1-610-667-7706
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