Category: Company Updates

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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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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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Anthera Update (1-19-13)

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[…]

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Pacira Update (1-18-13)

On a positive note, Pacira pre-released some of their key Q4 financials. The company expects Q4:12 and FY12 revenues to come in above Wall Street consensus estimates, driven by higher net sales of Exparel.  Q4 sales of the drug are targeted at $7.8 million, and total revenues are estimated at $10.5 million, compared to $4.2[…]

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

Isis’ 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 Company’s antisense technology. The FDA approval triggers a $25 million milestone payment[…]

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Pharmacyclics Update (1-18-13)

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.  First, the company is about to open RESONATE 17 – a likely fast-track registration trial of ibrutinib (the fourth[…]

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Isis Update (1-18-13)

Isis’ stock has been strong, pre- and post-JP Morgan. Wall Street is beginning to warm up to the story, as we believe; the deep pipeline from late-stage to early-stage compounds is attracting more investors.  The recent partnerships with Biogen and AstraZeneca for certain early-stage drug development candidates have convinced some that antisense has real potential. The[…]

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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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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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Anthera Update (1-18-13)

Anthera has switched gears as they recently disclosed that development program testing blisibimod in lupus is on hold as the company searches for a partner that will fund further development. This is a disappointment as ANTH had previously planned to start Phase III development for lupus this year.  ANTH now says that that they are[…]

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Incyte Update (1-18-13)

Incyte’s stock has had a nice move to start the year. The company presented at JP Morgan and did a good job of detailing how they will grow Jakafi sales.  Importantly, some on Wall Street also believe that INCY has learned a lot from the launch over the last year and are positioned to grow[…]

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