With Jason Chew and Juan Pedro Rodríguez Serrate We are coming close to the top-line data release of Celsion’s Phase 3 trial of Thermodox in primary liver cancer. We have previously discussed our consensus view on the company throughout the year(CLSN – Quick Take- It’s Bear Territory , 3 Phase III trials set to read […]
ONTY – Preparing For The Next Move
Oncothyreon Inc (ONTY)-Nasdaq Oncothyreon’s getting a lot of attention ahead of its near term catalyst set for Q1 2013 with the final analysis of its pivotal START trial. Results expected during January to February 2013. Daily chart On 11/7/2012, along with the negative sentiment in the overall US markets, and especially in the Biotech sector, […]
3 Phase III trials set to read out in 2013 – ONTY, CLSN, NLNK
With Patrick Crutcher Some of the biotech sector’s most highly anticipated catalysts approach in early 2013. Nearly every issues has been debated upon between the first two companies, while the third is relatively unknown amongst most investors. Admittedly, it is very difficult to come to a clear consensus on the outcome of each study. They […]
What to expect at SABCS12 from Celldex
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 […]
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 […]
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 […]
CPRX – Catalyst Pharmaceutical Partners – Promising But Still Early
Catalyst Pharmaceutical Partners Inc. (CPRX) -NasdaqCM Catalyst: Phase IIb trial results Sentiment : Bullish Tiny Catalyst Pharmaceutical Partners is expected to disclose top-line results from its pivotal Phase IIb study of CPP-109 for the alleviation of cocaine addiction in mid-November. CPP-109 is a very promising drug in a field otherwise littered with failure. Should it […]
ZIOP – Ziopharm is undervalued
We have previously posted a long look at Ziopharm Oncology here. We feel the story is worth reiterating given near-term events and our view that the company is undervalued. Recent volatility due to a bearish, yet misleading article have opened up an opportunity. Upcoming events — Update overall survival data from their Phase 2 study […]
Biotech and Pharma earnings preview
Starting after-hours on Tuesday, we’ll see a lot of biotech and pharmaceuticals earnings, guidance, and outlook on their current programs. With the market cooling off, companies will be under pressure to meet investor expectations. Next week a number of sector leaders will kick things off. We’ve listed the updates in chronological order. Amgen (Nasdaq: AMGN) […]
ISIS and AEGR – Where do they stand after the FDA Advisory Committee meetings?
October 17 and 18, 2012 saw back-to-back meetings of the FDA Endocrine and Metabolic Drugs Advisory Committee (EMDAC) to review pending new drug applications (NDAs) for two drugs for homozygous familial hypercholesterolemia (HoFH): lomitapide from Aegerion Pharma (NASDAQ: AEGR) and mipomersen/Kynamro from Sanofi/Genzyme and Isis Pharma (NASDAQ: ISIS). As Chimera predicted, both drugs received positive […]
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) […]
