Expert Financial Analysis and Reporting

Investment View Celldex has a broad array of clinical trials underway or in planning that involve five drugs. However, most of these trials are in an early exploratory stage and are designed to provide signals of activity for designing subsequent trials that could lead to approval. As such they are not likely to have much […]

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 […]

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 […]

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 […]

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 […]

Introduction A number of subscribers have suggested that I write more on recent news events that relate to companies that I follow. This note is in response to these requests giving my take on some recent news releases. I would appreciate your feedback on whether this is of any value to you. I am considering […]

Immuno-Oncology Promises to be the Next “Big Thing” In Biotechnology Purpose of the Report Immuno-oncology has been the hottest area in biotechnology in 2014 and this promises to continue in 2015 and the coming decade. This report attempts to provide a basic background to give readers a layman’s view of some of the new technologies […]

Investment Thesis Celldex held a conference call after the close on Friday, November 14, 2014 to discuss the interim results of the phase 2 trial of rindopepimut in recurrent glioblastoma multiforme (also referred to as GBM). The results were quite positive-much better than I expected- and I believe that they can be the basis for […]

This Has Been a Tough Correction The recent sharp market correction and rotation out of growth stocks like biotechnology and technology has had a major impact on the small biotechnology names that I specialize in. The correction has been stomach churning for me even though I have been through this many times before. I am […]

Report Overview Celldex released interim data on the ReACT trial of rindopepimut in recurrent glioblastoma at the Society for Neuro-Oncology (SNO) on November 24, 2013. I am always cautious on rushing out with an interpretation of data from a clinical trial shortly after it is released. There are many different data points in a trial […]