Expert Financial Analysis and Reporting

Definition of Key Terms Used in This Report Engineered Autologous T-cells (eACTS): These are T-cells that are removed from a patient and genetically engineered to increase their activity against cancer cells. They are then expanded into billions of clones that are reinfused into the patient where they continue to differentiate and attack cancer targets. Chimeric […]

The FDA has decided to lift the clinical hold on the ROCKET trial. Lifting the hold is not a great surprise but the quick turnaround is. This is a strong signal from the FDA that it views the troublesome side effects of CAR-T therapy to be an acceptable risk when weighed against its dramatic therapeutic […]

Investment Perspective I have been watching Kite and Juno for nearly two years and have occasionally written on the companies. I am almost through with a report on Kite that should be published soon. As people who follow me know, I am very much attracted to potentially paradigm changing technologies like CAR-T and other related, […]

Overview of COPD Cytokinetics announced today that it is beginning a phase 2 trial of CK-2127107 in chronic obstructive pulmonary disease (COPD). The trial is being conducted by CYTK’s partner Astellas. COPD usually is caused by long time smoking and has two main forms: (1) chronic bronchitis, which is characterized by a long-term cough with […]

Teva announced today the launch of its AB rated generic to Imitex (sumatriptan). Remember that Antares books revenues from Teva with a one quarter lag so there should be no revenues reflected from the launch in the 2Q, 2016 report from Antares. Teva will include this product in its bundling agreements for generics with pharmacies […]

Organization of Report The first five pages of this report (section 1) provide a quick summary of my view of AMAG’s business outlook and how this leads to my investment thesis. It does not go into great depth as it is intended to give an impression so that you can decide whether you want to […]

Overview The naming of five distinguished scientists with extensive knowledge and expertise in immune-oncology to Northwest’s scientific advisory board is the first of what I hope will be a number of steps that Northwest will take to fight back against a massive short selling attack on the Company. This has destroyed the stock price and […]

Investment Thesis Veltassa continues its slow but steady launch. The May results were in line with my projections and I think they were also generally in line with those of the Street. In the first year of a launch the new reality is that managed care sets up significant reimbursement hurdles. We are seeing this […]

Report Overview Antares and AMAG Pharmaceuticals are jointly developing a new subcutaneous formulation of AMAG’s key drug Makena which is currently administered as a deep and painful intra-muscular injection. I recently did a detailed report on the medical profile of Makena and concluded that most (all) of Makena’s sales- estimated at $310 to $340 million […]

Investment Thesis The receipt of a CRL for ZS-9 delays its possible approval by perhaps one year or more which substantially enhances the first mover advantage of Veltassa. AZN comments on the CRL minimize the potential that the mechanism of action of ZS-9 (which exchanges sodium for potassium) is a safety concern, but I am […]