Expert Financial Analysis and Reporting

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 Thesis Antares is preparing to launch Otrexup in January 2014; it is the first product it has ever introduced and investor attention is keenly focused on the launch. This post is not a comprehensive overview and if you would like to see more in-depth research on other aspects of the Company, I would refer […]

Investment Thesis By every measure, the launch of Ofirmev which began in January 2011, has been a spectacular success and continues to exceed investor expectations and management guidance. The revenue guidance was just raised for the third time this year to $107 to $109 million, up from $105 to $107 million and $102 to $105 […]

Note: Comprehensive reports are now available to paid subscribers and can be found in the Reports section. Investment Background and Thesis This post is the summary of a much more extensive report that is available to paid subscribers. In that report, I discuss rindopepimut and other cancer vaccines for GBM in more detail. In my initial report on […]

Key Takeaways From 3Q, 2013 Conference Call The BENEFIT-ALS trial of tirasemtiv has nearly completed enrollment and Cytokinetics (CYTK) believes that topline data will be reported as early as the American Academy of Neurology (AAN) Meeting in Philadelphia in April 2014. The most likely path forward in the event that the data is positive is […]

This post is an excerpt from the report: Celldex: Pipeline Promise Has Been Embraced by Wall Street Comprehensive reports are now available to paid subscribers and can be found in the Reports section. Review of Amazing and Volatile Stock Price Performance From the closing price on December 30, 2011 through October 1, 2013 Celldex’s (CLDX) stock […]

Background on the Complete Response Letter This note focuses on the implications of the complete response letter (CRL) received by Alimera (ALIM) for Iluvien. This product was developed by pSivida (PSDV) but was partnered with Alimera. This report deals only with the investment significance for pSivida. Alimera announced that it had received another CRL from […]

Investment Overview In my last note, I wrote that I thought the ATOMIC-AHF, phase IIb trial of the intravenous dosage form omecamtiv mecarbil in acute heart failure might not reach its primary endpoint of dyspnea (shortness of breath), but that this would not deter Amgen from beginning phase III trials in 2H, 2014. Wall Street […]

Cadence (CADX) announced that the US patent office has issued an initial action on the re-examination of one of two patents covering Ofirmev, the ‘222 patent on formulation. The PTO rejected certain claims in the patent while upholding others. However, all of the claims remain valid and in place until the PTO issues its final […]

Investment Thesis Cadence (CADX) reported another strong quarter for Ofirmev and in my mind the only question about the launch is the magnitude of success. In this report, I go through arguments that suggest that Ofirmev sales in a conservative case could reach $350 million in 2018 and in an optimistic case could reach $730 […]