QUARTERLY UPDATE – stock has been volatile since the release of their financials last week (2/7). However, given that the stock has had an incredible start to 2013 (still up >50% YTD), a pullback was not unexpected, and the shares have since made an impressive recovery. Pullbacks after very strong moves that back and fill[…]
Pomalyst (“Pom”) was approved by the FDA for the treatment of multiple myeloma (MM) patients who have failed two prior therapies, providing the beginning of another growth driver for CELG. The Fast Track approval was based on response rates. Despite being the third “imid,” Pom’s label has a black box warning (just like Revlimid &[…]
January 31, 2013 The Life Sciences Report: Watchlist 2013 by George S. Mack Which biotech companies will take off in 2013? To zero in on possible winners, The Life Sciences Report teamed up with Sagient Research to crunch the numbers for companies with potential catalysts on the calendar. The results were sent to experts who, based on their[…]
NVAX has cleared an important hurdle tied to the government funding for their seasonal and pandemic flu vaccine program. The U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) has completed an In-Process Review of the company’s contract. Subsequently, BARDA has notified NVAX that a milestone decision has been made to[…]
OGXI has started their fourth Phase II trial testing OGX-427 in cancer patients. Borealis-2 is being initiated as an investigator-sponsored, randomized, controlled Phase II trial of 427 in patients with advanced or metastatic bladder cancer (http://clinicaltrials.gov/ct2/show/NCT01454089?term=Oncogenex&rank=1). This trial will evaluate the potential of ‘427 to work synergistically with second- or third-line chemotherapy to overcome treatment[…]
February 1, 2013 GLORY DAYS The performance of biotechnology stocks since the start of 2013 has been no less than stellar. The BTK and NBI are up 9% and 8% respectively, and the MTSL Model (+21%) and Traderâs Portfolios (+37%) are up sharply as well (see below).  Two of BioInvestâs recommended stocks â CNDO (+63%)[…]
PCYC = Janssen (JNJ) To Begin Front-Line Phase III Mantle Cell Lymphoma and Phase II Refractory Follicular Lymphoma Studies. We have discovered that www.clinicaltrials.gov recently (1/29) posted two new ibrutinib studies. First, and most important in our view, is the Phase III trial of ibrutinib in front-line mantle cell lymphoma (MCL) in combination with bendamustine[…]
Anthera announced last week that they priced a public offering of 60 million shares at $0.66 per share, which will add $40 million to their balance sheet. Jefferies is acting as sole book-running manager in the offering and Leerink Swann is acting as co-manager. These are quality investment banks and it is an impressive accomplishment for[…]
FDA Grants Ibrutinib Breakthrough Therapy Designation – Could Be On The Market in Q1:14 – Raising BUY LIMIT and TARGET PRICE. The FDA has granted PCYC’s ibrutinib Breakthrough Therapy Designation for the treatment of relapsed/refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglubinemia (WM). This is a major positive for Pharmacyclics that could conceivably lead to[…]
February 01, 2013 Below is a pdf for Issue 747 of the Medical Technology Stock Letter. [gview file=”http://50.87.166.114/wp-content/uploads/2013/02/MTSL-747-February-1-2013.pdf” save=”1″]
Isisâ Kynamro was approved by the FDA for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The approval is the first for a systemic antisense drug (Vitravene for CMV of the eye was approved in 1998), and represents a major milestone for the Companyâs antisense technology. The FDA approval triggers a $25 million milestone payment[…]
We attended the Pharmacyclics‘ presentation and breakout session at JP Morgan. While the company repeated much of the powerful ASH data from a month earlier, we did learn some new and not unimportant pieces of information. Â First, the company is about to open RESONATE 17 – a likely fast-track registration trial of ibrutinib (the fourth[…]
