As Celldex Therapeutics comes closer to their presentation at the San Antonio Breast Conference Symposium this weekend, we wanted to provide a primer on their CDX-011 program. With around $370 million in market capitalization, we do not believe the market is adequately valuing the CDX-011 program. We plan to walk thru the data and potential […]
2012 ASH Meeting – Myelofibrosis, Lymphoma, Myeloma
It’s going to be a busy few days at ASH, which begins December 8 in Atlanta. A huge amount of data will be presented; here is an overview of some interesting abstracts. YMI: YM Biosciences Title: Phase I/II Study of CYT387, a JAK1/JAK2 Inhibitor for the Treatment of Myelofibrosis YM Biosciences will present final safety […]
FOLD – Getting Ready For The New Uptrend
Amicus Therapeutics, Inc. (NASDAQ: FOLD) With FOLD on the move again, we wanted to look at how the stock is performing from a technical perspective , especially after Patrick’s report “FOLD – Bullish on Amicus Therapeutics” which highlighted the upcoming catalysts for this company. In particular, the top-line data from their Phase 3 study of […]
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 […]
FOLD – Bullish on Amicus Therapeutics
With Phase 3 data expected from Amicus Therapeutics (NASDAQ : FOLD), we wanted to take the time to do a thorough analysis of the trial and what to expect. Jason Chew has covered Amicus since early 2012, so their story should be familiar for our readers. Now, we would like to review some insightful points […]
IBB – A Closer Look at the Market’s Direction
In my previous report “IBB – Nasdaq Biotechnology Index – Reaching a Critical Point ” I tried to find out if the technical correction in the index $IBB reached a support area, and the price found a support line around the Fibonacci 61.8 or the weekly support line at 126.90 points. Today the price reached […]
INCY, LLY – Baricitinib at ACR 2012
Incyte Corp and Eli Lilly participated in an investor meeting following the presentation of Phase II data for their jointly developed JAK inhibitor, baricitinib, at the American College of Rheumatology (ACR) on November 13. Baracitinib is a selective and highly potent JAK1/2 inhibitor entering Phase III studies in Rheumatoid Arthritis (RA). The companies described highly […]
ALNY – Troubled Legal Battle Ahead For Alnylam
With shares of Alnylam Pharmaceuticals (NASDAQ: ALNY) up well over 150% year-to-date, with 52 week highs at $21.38, we began an investigation into their current valuation and pending catalysts. Alnylam is a biotech company with technology/intellectual property rights on some key patents in the RNAi space, and some early-stage pipeline candidates for several indications. Unfortunately, […]
THLD – More uncertainty ahead for Threshold
As we previously suggested, Threshold Pharmaceuticals (NASDAQ: THLD) had some question marks about their future prospects of TH-302 in two key indications: pancreatic cancer and soft-tissue sarcoma. Recent data readouts have brought these issues into focus again. Although Threshold has a good cash position, we feel their lead (and only) drug, TH-302, will have a […]
FOLD – Phase II Amigal Co-administration Update
Amicus Therapeutics released updated data Thursday for its chaperone molecule Amigal (migalastat) for Fabry disease at the American Society of Human Genetics (ASHG) Annual Meeting. Results looked good, continuing to build on positive data presented earlier this year. This study looks at the ability of Amigal to increase the activity of Enzyme Replacement Therapies (ERTs) […]
DCTH – Commercial prospects and valuation
In our previous note, we discussed why we thought that a drug with orphan status, fast-track that tackles metastatic disease would receive a 6-month priority review. However, the FDA didn’t think Chemosat was elegible to get it and granted a 10 month review with a PDUFA date on June 15, 2013. The agency will convene […]
IBB – Nasdaq Biotechnology Index – Reaching a Critical Point
iShares Nasdaq Biotechnology (IBB)-NasdaqGM Typically, the best indicator of the action in our biotech portfolio is the $IBB. By looking at it we get the whole picture of the pressure that we as investors or traders in the biotech sector have felt in the past 4 trading weeks after the euphoria and the hype that […]
PBYI – Quick look at Puma Biotechnology
We wanted to take a moment to take a quick look at Puma Biotechnology (NYSE: PBYI). They recently raised $130M in cash from a public offering. The company has some notoriety due to the co-founder’s, Alan Auerbach, presence at the helm of the company(CEO and President). Prior to founding Puma, Mr. Auerbach served as founder, […]
Upcoming medical conferences – Q4 2012
With the beginning of November, we enter the home stretch for some of the major medical meetings that will serve as pivotal events for some companies. We have attempted to list some of the higher profile conferences, but it’s entirely possible that some will slip by us. November American Heart Association(AHA) Scientific Sessions – 11/3 […]
What we’re looking for at ASH 2012
On Monday, November 5th, abstracts submitted to 2012 Annual Meeting of the American Society of Hematology (ASH) Annual Meeting will be published online. A time has not been released, but we have heard they will be released at 10AM Eastern time. Below are some comments on companies we expect to have a present at the […]
ACAD – The Last Run to The Parkinson’s Disease Psychosis Results
ACADIA Pharmaceuticals Inc. (ACAD) -NasdaqGM Catalyst: late Nov. P-III results for Parkinson disease Acadia reported a 100% patient enrollment on Sep 05th: ACADIA Pharmaceuticals Announces Completion of Enrollment in Phase III Pimavanserin Trial in Parkinson’s Disease Psychosis Top-Line Data Expected in November 2012, as I mentioned earlier in my last report and since 09/07 the […]