In one of the most surprising news today, Dynavax Technologies Corporation (NASDAQ:DVAX) has announced that the first clinical data of their HEPLISAV has shown increase in the protection rate for chronic kidney disease patients. The data will be presented publicly in a poster session on Saturday, October 31, 2009 at the Annual Meeting of the Infectious Disease Society of America (IDSA) in Philadelphia, Pennsylvania.

Dynavax Technologies Corporation is a biopharmaceutical company that discovers and develops product candidates like Toll-like Receptor also known as TLR. HEPLISAV is a Phase 3 adult hepatitis B vaccine that provides increased and rapid protection to the patients with fewer doses compare to the current licensed vaccines available in the market. During the Phase 3 trial of HEPLISAV around 2500 individuals were vaccinated with

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Yesterday, Dynavax Technologies Corp. (DVAX) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on its late-stage hepatitis B vaccine (HBV) Heplisav which is being developed for patients suffering from chronic kidney disease. As a reminder, Heplisav was on clinical hold in the U.S since Mar 17, 2008 following the report of the severe adverse event (SAE) of Wegener's granulomatosis. The SAE was reported in the phase III study in healthy adults conducted outside the U.S. Wegener's granulomatosis is an uncommon disease which results in the inflammation of blood vessels .The vaccine is being studied for both healthy adults and patients with end-stage renal disease. Consequent to the regulatory issues, the partnership with Merck & Co. Inc. (MRK) for Heplisav ended on December 19, 2008. All rights relating to the development and commercialization of Heplisav reverted to ...

For Immediate Release

Chicago, IL – August 27, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: China Life Insurance Company (LFC), American International Group (AIG), Deutsche Bank (DB), Morgan Stanley (MS) and Amgen (AMGN).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Wednesday’s Analyst Blog:

China Life’s Profits Grow

China Life Insurance Company (LFC), the leading life insurer in China, has posted a 15% rise in profits in the first half of 2009 compared to the prior-year period. The company earned 18.2 billion yuan ($2.7 billion) in the first half

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In a latest development, the U.S. Medicare agency will seek an advisory panel’s recommendation regarding the use of anemia drugs developed by Amgen (AMGN) as well as Johnson & Johnson (JNJ), in patients with chronic kidney diseases. The advisory committee is likely to review the use of erythropoiesis-stimulating agents (ESAs) for anemia in patients with chronic kidney disease at a meeting to be held on March 24, 2010.   While, Johnson & Johnson has one ESA, Procrit, Amgen has two ESAs in its product portfolio, Aranesp and Epogen. Further review of these drugs became necessary as recent studies conducted over the past few years have shown that high doses could lead to heart complications or death in some cases. Accordingly, the FDA ordered strong warnings to be added to the labels.

During the second quarter, Amgen’s ESA franchise contributed 36% to total revenues. Aranesp sales declined 16% to $693

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The DIRECTV Group, Inc. (NASDAQ:DTV) today reported that second quarter 2009 revenues increased 9% to $5.22 billion, operating profit before depreciation and amortization1 (OPBDA) increased 2% to $1.38 billion while operating profit decreased 12% to $702 million compared to last year’s second quarter.

Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has acquired 100% rights to RenaZorb® (a family of compounds represented by SPI-014, also known as RZB-014), a lanthanum-based nanotechnology compound with potent and selective phosphate binding properties, for all human and non-human indications.

About RenaZorb®

RenaZorb, or SPI-014, is a non-aluminum, non-polymer, non-calcium, lanthanum-based nanotechnology with highly potent and selective phosphate binding properties, for the potential treatment via oral administration, of hyperphosphatemia, (high phosphate

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Yesterday, AMAG Pharmaceuticals Inc. (AMAG) reported second-quarter net loss of $26.5 million, or $1.55 per share, which was slightly higher than the Zacks Consensus estimate of $1.53. The company had reported a net loss of $17.0 million, or $1.00 per share, in the year-ago period.

The higher quarterly net loss is attributable to a 39% increase in year-over-year operating expenses. Research and development expenses rose 43% as the company is working on expanding its manufacturing capabilities and development infrastructure. Selling, general and administrative expenses also increased 37% for commercialization of anti-anemia drug candidate, Feraheme.

Since Feraheme is a very important product for the company, we expect investor focus to remain on the initial sales ramp of the product.

As a reminder, the US Food and Drug Administration (FDA) granted marketing approval to Feraheme injection on June 30. AMAG officially launched Feraheme in the U.S. on July 13. It

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PennyOmega.com Stock Report!

PennyOmega.com Hot Stock News & Alerts!

 

Tuesday July 28, 2009

PennyOmega.com Stock Report!

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Signature Bank (Nasdaq: SBNY), a New York-based full-service commercial bank, today announced results for its 2009 second quarter ended June 30, 2009. Net income for the 2009 second quarter reached $12.0 million, or $0.32 diluted earnings per share, compared with $10.9 million, or $0.36 diluted earnings per share, for the 2008 second quarter. Excluding the after tax effect of the FDIC Special Assessment of $3.5 million, net income for the quarter was $13.9 million, or $0.38 diluted earnings per share, an increase of 28.5 percent.

Bristol-Myers Squibb Company (NYSE:BMY) is commencing today, through its wholly owned subsidiary Puma Acquisition Corporation,

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Yesterday, Massachusetts-based biopharmaceutical company AMAG Pharmaceuticals Inc. (AMAG) launched the Feraheme (ferumoxytol) Injection in the U.S. It is an intravenous iron replacement therapy to fight anemia in patients with chronic kidney disease. The drug can be used by patients irrespective of them undergoing dialysis. Wholesalers and specialty distributors will primarily distribute Feraheme in the U.S. More specifically, AMAG will use approximately 150 seasoned professionals which includes a 80-person specialized sales force to sell and market the drug. For every 510 mg vial, the wholesale acquisition cost (WAC) of Feraheme is $396.78. Iron deficiency anemia is a significant problem in patients with chronic kidney disease and often goes underdiagnosed and undertreated. We feel peak sales of Feraheme could reach $500 million. As a reminder, Feraheme is AMAG’s lead anti-anemia drug candidate. The company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration ...

For Immediate Release

Chicago, IL - July 2, 2009 - Zacks Equity Research highlights AMAG Pharmaceuticals Inc. (AMAG) as the Bull of the Day and Palm, Inc. (PALM) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Everest Re (RE), Ace Limited (ACE) and Montpelier (MRH).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676.

Here is a synopsis of all five stocks:

Bull of the Day:

AMAG Pharmaceuticals Inc. (AMAG) develops superparamagnetic iron oxide nanoparticles for use in pharmaceutical products. The company's focus is on developing IV iron replacement therapy for anemia in chronic kidney disease and imaging agent to aid in diagnosis.

The company filed the NDA for its lead drug Feraheme in December 2007, and the drug was approved by the FDA on

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After a series of delay, late yesterday (June 30) the FDA finally granted marketing approval for AMAG Pharmaceuticals, Inc.'s (AMAG) Feraheme (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.The FDA recommended an initial dose of 510 mg IV injection followed by a second 510 mg IV injection three to eight days later. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.AMAG plans to launch Feraheme in the U.S. during the second half of this month. Feraheme will be distributed primarily through wholesalers and specialty distributors. The Company will market and sell Feraheme through its commercial organization consisting of ...