Vertex released interim data May 7th of an ongoing combination study of VX-809 and KALYDECO in Cystic Fibrosis patients with two copies of the F508del mutation. Results were very good- VX809 plus Kalydeco led to significant improvements in lung function (as measured by absolute change in percent predicted FEV1). Treatment Group Absolute Improvement from Baseline in Lung Function (FEV1) […]
Trade Ideas for some upcoming catalysts
We wanted to throw out some trading ideas for some stocks that we are following, but may not necessarily get full write-ups on in time. Ideally, we will have research pieces on some of the companies below in the near future. – On Thursday January 26th, Celgene(NASDAQ:CELG) will be reporting earnings and financial guidance for […]
Anticipated EMA decisions in the first half of 2012
Following our post on upcoming FDA decisions/panel, we wanted to do the same but for European Medicines Agency (EMA) decisions. As you will see, most of the events listed below just have an estimated date by which we will hear an update. This is largely because the way drugs are approved in the EU is […]
Upcoming FDA Decisions and Advisory Panels
To help save everyone some time, we went ahead and rounded up the upcoming FDA PDUFA dates and FDA Advisory Committees. We will have trade ideas and opinions on some of these events in the near future. We have highlighted some of those which we feel are the biggest importance to the market with asterisks(*). […]
Regulatory catalysts expected by end of 2011
This post is meant to highlight some of the key regulatory decisions that are expected by year’s end 2011. We have highlighted some of those catalysts which should have a significant impact on price. We should have some coverage/ideas coming up for some of these that we haven’t already written about. FDA Decisions or FDA […]
Run Biologics- The JAKs Are Coming
A new class of drugs targeting the JAK kinases is set to challenge today’s biggest selling biologics for the treatment of arthritis and other inflammatory diseases. Heading this class is Pfizer’s tofacitinib; this potent, but relatively un-selective JAK inhibitor demonstrated positive results in five pivotal trials earlier this year. Pfizer intends on filing for marketing […]
Vertex is Overvalued
Don’t get me wrong here, I think Vertex’s telaprevir is an incredible development that will usher in a new era in HCV treatment. Current estimates of the HCV market are about $2.5 billion, with the number increasing 4-fold as new therapies enter the market- that’s potentially $10 billion, getting close to the $15 billion expected […]
