Investigation Overview
March 11, 2016 (Shareholders Foundation) - An investigation on behalf of investors of Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares over potential securities laws violations by Celldex Therapeutics and certain of its directors and officers in connection certain financial statements was announced.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Celldex Therapeutics, Inc. (NASDAQ:CLDX) concerning whether a series of statements by Celldex Therapeutics regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
On March 07, 2016, Celldex Therapeutics, Inc announced that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other. In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months). Celldex Therapeutics, Inc said that based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time.