Category: Company Updates

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Novavax Update (4-25-13)

NovaVax – Why VLPs are VIPs. The key to the NVAX vaccine platform technology is the use of virus-like particles (VLPs) to safely deliver key immune-identifying proteins to the body.  Importantly, proof of concept is in place as VLPs are recombinant particles similar to currently marketed vaccines.  Merck’s Recombivax HB and GSK’s Engerix B are recombinant[…]

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Novavax Update (4-2-13)

NovaVax released positive Phase II data from their respiratory syncytial virus (RSV) vaccine development candidate, RSV-F.  RSV-F exhibited a robust antibody response and clean safety profile in the trial that enrolled 330 women of childbearing age. The trial is a major step towards the commercial viability of the very first RSV vaccine candidate ever for use[…]

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Pharmacyclics Update (4-5-13)

Pharmacyclics (4/5/13) – Ibrutinib – Expanding the Potential – Pancreatic Cancer, Combination Therapies and Recovery of Functional Immunity – Reiterate BUY UNDER 80 and TARGET PRICE OF 115. The AACR meeting begins this weekend in Washington, D.C. An overwhelming number of studies by every oncology company, both preclinical and human trials, are due to be[…]

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Incyte Update (3-18-13)

Incyte’s stock is down this morning after disclosing that a UK patient taking Jakafi has died from a rare brain infection, progressive multifocal leukoencephalopathy (PML). It is unclear whether Jakafi caused the infection and that it is the only reported case among nearly 10,000 patients who have taken the drug.  A review of the clinical[…]

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Pharmacyclics Update (4-24-13)

Pharmacyclics (4/24/13) – Completes Enrollment of RESONATE and SPARK Well Ahead of Schedule – Continue to Expect Ibrutib on Market This Year, Ahead of All Expectations. Completion of both trials, RESONATE (CLL) and SPARK (MCL), approximately 6-9 months ahead of forecasts supports our belief that ibrutinib is on track to be approved in the U.S. in[…]

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Pharmacyclics Update (4-17-13)

Pharmacyclics (4/17/13) – JNJ Opens Ibrutinib Early Access Program (EAP) – Expect FDA Filing By Q3/Approval By Year-End – Raising BUY LIMIT to 90 and TARGET PRICE to 125 Last night, Janssen (in conjunction with Pharmacyclics) filed a Phase 4 Open Label Treatment Protocol for patients with relapsed/refractory mantle cell lymphoma (MCL) on www.clinicaltrials.gov. This early[…]

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Aastrom Update (3-27-13)

Aastrom (3/27/13) – ASTM Restructures to Focus on Orphan Drug Indication, Lowering BUY and TARGET PRICE – Aastrom dropped a bomb premarket today when new CEO, Dominick Colangelo, announced that the company is shelving their Phase III CLI program and cutting half their workforce after completing a comprehensive strategic review.  ASTM will now focus on[…]

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Pharmacyclics Update (3-06-13)

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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Alkermes Update (4-17-13)

Alkermes (4/17/13)– Positive MDD Data Supports Increased BUY LIMIT and TARGET PRICE Alkermes eleased rather positive Phase II data from ALKS 5461 for the treatment of major depressive disorder (MDD).  ‘5461 is a non-addictive opioid modulator, a combination of ALKS-33 and buprenorphine. The Phase II trial was highly statistically significant across major depression endpoints. The[…]

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Pharmacyclics Update (4-10-13)

Pharmacyclics (4/10/13) –Major Ibrutinib Competitor – ABT-199 – Still Seeing Tumor Lysis Syndrome; Richter’s Transformation Issues Completely Overblown. At the AACR, Rod Humerickhouse, M.D., Ph.D. of AbbVie presented an update on ABT-199, a Bcl-2 inhibitor, under development for hematologic malignancies similar to PCYC ibrutinib.  Recall back in January, AbbVie suspended trials as two patients died from tumor lysis syndrome due (TLS) to[…]

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Pharmacyclics Update (3-25-13)

Pharmacyclics (3/25/13) – BEAR RAID GIVES US OPPORTUNITY, PCYC BACK UNDER BUY LIMIT – Last week, Pharmacyclics shares dropped precipitously on the heels of several items – none of which were directly related to ibrutinib’s clinical trials, approval timeline and, hence, commercial potential.  First, both ARIA’s Iclusig and ONXX’ Krypolis – two of the most[…]

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Pacira Update (3-01-13)

Pacira posts Phase 3 nerve block study; completes EXPAREL pilot hernia study. Pacira has posted the design and is about to begin a Phase III nerve block study with EXPAREL in patients undergoing thoracic surgery. The trial will enroll 180 patients and data collection is due by August.  Nerve block is the next major market for[…]

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