Expert Financial Analysis and Reporting

Investment Significance of Upcoming Conference Call Celldex (CLDX) has raised expectations for positive results for rindopepimut in recurrent glioblastoma. It will hold a conference call on Monday, November 25 at 8:30 AM to discuss results on the use of rindopepimut in recurrent glioblastoma. The actions of Celldex clearly indicate that the data will be positive. […]

Investment Thesis I think that Repligen’s (RGEN) bioprocessing businesses is one of the best business models that I have seen in my many years as an analyst. Products used in bioprocessing have very long product lives because changing the manufacturing process for a biological product once it is approved or after it has completed phase […]

  Purpose of This Report This is the first of a series of reports on Discovery Laboratories. Instead of publishing an extensive report (which I have actually written), I thought that I would publish smaller excerpts that may be easier to digest. I am starting with the most important part that goes through my thinking […]

Investment Viewpoint ImmunoCellular has extremely important data upcoming on the phase II trial of ICT-107 in newly diagnosed glioblastoma; topline results are anticipated in 4Q, 2013 or 1Q, 2014. There are four biotechnology companies- ImmunoCellular Therapeutics (IMUC), Northwest Biotherapeutics (NWBO), Agenus (AGEN) and Celldex (CLDX)-that currently are in phase IIb and III trials of cancer […]

Investment Background and Thesis In my initial report on Celldex, I highlighted four interesting products that the Company has in development. Two of these are in randomized phase II or III trials that could be the basis for regulatory filings: rindopepimut for glioblastoma (GBM) and CDX-011 or glembatumab for triple negative GPNMB positive breast cancer. I […]

Review of Amazing and Volatile Stock Price Performance From the closing price on December 30, 2011 through October 1, 2013 Celldex’s (CLDX) stock price increased 15 fold from $2.60 to $37.83; its shares have recently backed off to about $26.00. The number of shares outstanding nearly doubled over this 21 month timeframe from 44.2 million […]

Putting Malaria Vaccine Results in Perspective for Agenus Glaxo (GSK) has just released interim (18 month) results on its phase III trial conducted in sub-Saharan Africa for its malaria vaccine, RTS,S; this follows previous interim reports at 6 and 12 months. The results are not as good as the results normally seen with childhood vaccines […]

Investment Scenarios: The Positive and Negative Case pSivida (PSDV) has a very important binary event upcoming on October 17, 2013; this is the PDUFA date for Iluvien, an ocular implant for diabetic macular edema that was licensed to Alimera (ALIM). I cannot answer the question of whether the government shutdown might delay the PDUFA date […]

Surfaxin is Finally Cleared for Commercialization in the US The long saga for Discovery Laboratories (DSCO) that began with the first filing of an NDA for Surfaxin in April of 2004 has finally come to an end as the FDA has cleared Surfaxin for marketing. The NDA was actually approved in March 0f 2012, but […]

Investment Background Cytokinetics and Amgen first presented data from the ATOMIC HF trial at the European Society of Cardiology Congress (ESC) on September 2, 2013. This was a 48 hour dose ranging study in patients who were hospitalized with heart failure. The objective of the study was to determine pharmacokinetic (describes how the body affects […]