Tag archive for ‘varilumab’
Celldex: ACT IV Trial of Rintega in Newly Diagnosed Glioblastoma has Been Terminated (CLDX, Hold, $4.01)
ACT-IV Trial is Halted The independent Data Safety and Monitoring Board (DSMB) just completed its second interim review of the phase 3 ACT IV study of Rintega (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma. The analysis concluded that the trial will not achieve statistical significance for its primary endpoint of overall survival. Celldex received […]
Celldex: Meaningful Data on Two Lead Products, Rintega and glembatumumab, is not Likely Before 2017 (CLDX, Hold, $16.99)
Key Points; The big news of the 2Q, 2015 conference call was that the FDA has discouraged Celldex from filing an NDA on Rintega based on results in the phase 2 ReACT trial in recurrent glioblastoma. It was widely expected that they could file for approval in mid to late 2016. This caused a nearly […]