According to the lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that:
- clinical trials revealed significant concerns related to the benefit-risk ratio and overall survival data of Ublituximab (an investigational glycoengineered monoclonal antibody for the treatment of B-cell non-hodgkin lymphoma, chronic lymphocytic leukemia (“CLL”), and relapsing forms of multiple sclerosis) and Umbralisib (or UKONIQ, an oral inhibitor of PI3K-delta and CK1-epsilon for the treatment of CLL, marginal zone lymphoma, and follicular lymphoma);
- accordingly, it was unlikely that the Company would be able to obtain U.S. Food and Drug Administration (“FDA”) approval of the marginal zone lymphoma (“MZL”) and follicular lymphoma (“FL”) (the “Umbralisib MZL/FL NDA”), the rolling submission of a Biologics License Application (“BLA”) to the FDA for Ublituximab in combination with Umbralisib (together, “U2”), as a treatment for patients with CLL (the “U2 BLA”), the supplemental New Drug Application (“sNDA”) for Umbralisib to add an indication for CLL and small lymphocytic lymphoma (“SLL”) in combination with Ublituximab (the “U2 sNDA”), or the Ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (“RMS”) (the “Ublituximab RMS BLA”) in their current forms;
- as a result, the Company had significantly overstated Ublituximab and Umbralisib’s clinical and/or commercial prospects; and
- therefore, the Company’s public statements were materially false and misleading at all relevant times.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Attorney Advertising. Prior results do not guarantee a similar outcome.
