Category: Company Updates

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Isis Update (2-19-13)

GSK Begins Pivotal Trial For ISIS-TTR.  The company earned a $7.5 million milestone payment from their partner, GlaxoSmithKline (GSK), on the initiation of a Phase II/III trial for ISIS-TTR.  ISIS-TTR is an antisense drug development candidate for the treatment of transthyretin (TTR) amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral[…]

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

Janssen (JNJ) Begins Ibrutinib Long-Term Extension Study. Pharmacyclics’ 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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[*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 (2-15-13)

PCYC held its quarterly call this week, two days after announcing the receipt of a “Breakthrough Therapy Designation” from the FDA for ibrutinib in refractory MCL/WM. The plethora of positive data continues to build for ibrutinib, and management confirmed the NDA filing for relapsed/refractory MCL by year-end. No one knows exactly what the new designation[…]

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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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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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Incyte Update (2-15-13)

Incyte’s Q4:12 results exceeded Wall Street’s expectations, driving the stock up 10%.  Sales of Jakafi were strong, but more importantly, the Company’s guidance for 2013 was impressive and could prove conservative. It appears new COO Jim Daly, who joined INCY in October from Amgen, is having a very positive impact, effectively educating physicians of the[…]

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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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