[Breaking News] Pharmacyclics Update (3-6-13)

Janssen (JNJ) Begins Ibrutinib Long-Term Extension Study. Pharmacyclicsâ partner Janssen has filed to begin a Phase 3b study, enrolling 200 patients who have participated in ibrutinib studies. This is a long-term follow-up study to give patients ibrutinib for up to 3 years, a logical trial to continue to monitor the long-term safety and efficacy of[…]

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Posted on February 15, 2013 by admin

OncoGenex Update (2-13-13)

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[…]

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Posted on February 13, 2013January 24, 2018 by admin

GLORY DAYS

February 1, 2013 GLORY DAYS The performance of biotechnology stocks since the start of 2013 has been no less than stellar.Â 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). Â Two of BioInvestâs recommended stocks â CNDO (+63%)[…]

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Posted on February 1, 2013February 4, 2018 by admin

Pharmacyclics Update (1-31-13)

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[…]

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Posted on January 31, 2013 by admin

[Breaking News] Pharmacyclics Update (2-12-13)

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[…]

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Posted on February 12, 2013 by admin

[Breaking News] Isis Update (1-31-13)

IsisâÂ 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[…]

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Posted on January 31, 2013 by admin

Sangamo Update (2-13-13)

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[…]

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Posted on February 13, 2013January 24, 2018 by admin

Celgene Update (2-09-13)

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 &[…]

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Posted on February 9, 2013January 24, 2018 by admin

The Life Sciences Report (1-31-13)

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[…]

Posted on January 31, 2013 by admin

Novavax Update (1-25-13)

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[…]

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Posted on January 25, 2013January 24, 2018 by admin