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Expert Financial Analysis and Reporting

Tag archive for ‘glembatumumab’

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 […]

Comments on Agenus, Neuralstem and Celldex

SmithOnStocks Mailbox About the Mailbox: My mailbox comments are brief articles on stocks in which I am involved. These can come from recent events or from subscribers’ questions. They are meant to address specific issues about these stocks and are not full and balanced reports. Please refer to the Reports section of my website for […]

Celldex Pipeline Update and Investment Thesis (CLDX, Moving from Buy to Hold, $28.56)

Overview This report updates my investment thinking on Celldex and also provides a brief overview of its two late stage products. Rentega (rindopepimut) is a peptide cancer vaccine in late stage development in both recurrent glioblastoma (rGBM) and newly diagnosed glioblastoma multiforme ndGBM) brain tumors that express the EGFRvIII mutation; it could be approved in […]