Was a quiet day on the news front, so I will keep this short(er). I am just getting a sneaking suspicion that we are heading into another period where macro rules and biotechs will have a tough sledding but they have been resilient so far but I would be careful. Even when the market reversed, […]
June 11-EOD
It was an odd day in the market with weakness early followed but a rally in the afternoon that made it look like we would get to unchanged (or even green). Then we sold off in the afternoon only to make another run at green in the last hour. On the positive side, it was […]
June 7- EOD
[This was meant to be posted Friday afternoon but did not seem to go through, so you get a bonus EOD of today] I do not think there is not much out there to add from today. I will touch on a couple of themes but it was generally a bounce back day for the […]
May 29- EOD
It seemed like a nice selloff in biotech today. There were the occasional winners (INFI) but for the most part it was a sea of red today. The summer months can be difficult times for biotechs but they have been quite resilient and these sell-offs have ended up being good buying opportunities. 1. I want […]
Upcoming earnings and conferences this week
With the first quarter behind us, we look to updates across the biotech industry on new product launches and guidance for the year. We are also coming upon the summer medical conference series. Additionally, we briefly discuss 2 upcoming FDA approvals. Upcoming earnings releases and updates Monday, April 22nd After-Hours: ILMN Tuesday, April 23rd Pre-Market: […]
Whats next for ALXN, BMRN, INCY, MDVN, ONXX, REGN, VRTX
First quarter earnings for 2013 are on the horizon. We want to outline some of the main events for some of the larger biotech companies we follow. It can be hard to track the progress of such large companies, but there are meaningful updates still expected in the next 6 months. Alexion Pharmaceuticals (NASDAQ: ALXN) […]
Rheumatoid Arthritis Treatments: The Decade Ahead
Rheumatoid arthritis sufferers have seen dramatic improvements in the standard of care over the last 25 years. Prior to the approval of methotrexate (MTX) in 1988, the best that doctors had to offer were NSAIDs and analgesics to manage pain and inflammation. As the first approved disease modifying drug, MTX revolutionized RA treatment and is […]
Upcoming events for ALXN, BIIB, CELG, and VRTX
This is the fifth installment in our series about upcoming events across the biotech sector(see our 1st piece, 2nd piece, 3rd piece, 4th piece). This time around we want to take a look at some upcoming events at some larger biotech companies and what will be drivers for them going forward. Alexion Pharmaceuticals (NASDAQ: ALXN) […]
AASLD 2012 – An HCV Primer
It seems EASL has just ended, but AASLD is fast approaching, coming mid November. For HepC watchers, here is an overview of some companies that will be presenting at the Liver Meeting. Despite the tremendous progress made to-date, new advances keep it exciting. Gilead: Acknowledged leader in the race to bring an all-oral drug combination […]
An October full of data and decisions
With October underway, we felt the need to highlight some of the most important upcoming data readouts and regulatory decisions. This month is particularly busy on the regulatory side of things with 5 PDUFAs, 4 Advisory Committees, 6 FDA actions, and multiple potential European Medicines Agency(EMA) decisions. The events are listed in chronological order. Eli […]
VRTX – Vertex: Kalydeco Is The Key
Catalyst: North American Cystic Fibrosis Conference, October 11 Outlook: Neutral Ten abstracts from Vertex have been accepted at the North American Cystic Fibrosis Conference (NACFC). Investors will be keenly focused on the October 11 presentation titled, “The Investigational CFTR Corrector, VX-809 (Lumacaftor) Co-Administered with the Oral Potentiator Ivacaftor Improved CFTR and Lung Function in F508DEL […]
VRTX – Speculating on Vertex
In going through the database, I noticed that Vertex Pharmaceuticals (NASDAQ: VRTX) has a plethora of upcoming data that is worth mentioning. It’s data on literally the two hottest sectors: rare disease and hepatitis C(HCV). – Viral Kinetic Studies of Two Alios Nucleotides: Seven-day viral kinetic studies of the nucleotide analogues ALS-2200 and ALS-2158 are […]
VRTX – Vertex Sweat Chloride to FEV1 Correlation in Cystic Fibrosis
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 […]
