AMAG Pharmaceuticals Inc. (AMAG) reported a fourth-quarter fiscal 2009 net loss of $18.4 million, or $1.07 per share, which was lower than the year-ago loss of $21.8 million, or $1.28. The Zacks Consensus Estimate for the reported quarter was a loss of $1.08.   The lower loss in the quarter was attributable to higher revenues following the approval and subsequent launch of the Feraheme injection. The higher revenue in the quarter more than offset the higher operating costs and expenses in the quarter attributable to increased selling, general and administrative expenses incurred for the commercialization of Feraheme.   Revenue for the reported quarter came in at $13.1 million as opposed to $0.6 million in the year-ago period. Net product revenues of Feraheme stood at $12.8 million in the reported quarter, including $1.3 million of $11.5 million in previously deferred product revenues. Total operating costs and expenses for the

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Dynavax Technologies Corp. is a clinical-stage biopharmaceutical company committed to discovering and developing novel products to prevent and treat infectious diseases. They discover and develop a pipeline of Toll-like Receptor (TLR) product candidates. The Company’s clinical-stage product candidates include Phase 3 HEPLISAV ™ Hepatitis B Vaccine, Phase 1 Hepatitis C Therapy, and Phase 1 Hepatitis B Therapy. Dynavax Technologies Corporation trades on the NASDAQ Capital Market.

The Company’s lead product candidate HEPLISAV™ is a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines. Their global strategy is to develop HEPLISAV for populations that are less responsive to current licensed vaccines. This includes adults over 40 years of age, individuals with chronic kidney disease, and others.

The Company’s product candidates also include Universal Flu vaccine, a preclinical vaccine under a supply and option agreement with Novartis; AZD1419, a preclinical

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Recently, AMAG Pharmaceuticals Inc. (AMAG) stated that it expects net revenues between $12 and $13 million from its lead anti-anemia injectable product Feraheme for the fourth quarter of fiscal 2009 (ended December 31).

AMAG had launched the Feraheme (ferumoxytol) injection in the United States on July 13, 2009. It is an intravenous iron replacement therapy to fight anemia in patients with chronic kidney disease (CKD). The drug can be used by patients even if they are undergoing dialysis.

The company further stated that Feraheme has been purchased by more than 1,000 customers to date, approximately 60% of whom have bought the drug on a repeat basis. Management believes that approximately 60% of the demand for Feraheme since its launch has come from patients not undergoing dialysis.

AMAG believes that the total operating expenses incurred in the fourth quarter of 2009 will exceed that recorded in the immediately preceding quarter. The increase is

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Recently, Dynavax Technologies Corp. (DVAX) completed the acquisition of Symphony Dynamo, Inc. in a stock deal. Under this agreement, Dynavax issued 13 million shares of its common stock to Symphony. The company in return received $20 million in cash as well as rights to its own hepatitis C and cancer treatments held by Symphony. In the event of Dynavax partnering the programs for hepatitis C and cancer therapy, Symphony stands to receive half of the first $50 million received from any potential upfront and development milestones.   Under the deal, Dynavax also issued 5-year warrants to Symphony for 2 million shares of the acquirer’s common stock at an exercise price of $1.94 per share. Dynavax cancelled the existing warrants for 2 million shares held by Symphony. The transaction further allowed Dynavax to delay a $15 million payment due to Symphony by 20 months. The amount, which is due ...

Dynavax Technologies Corp. (DVAX) announced recently that it has received approval from the European Union to make part of its hepatitis B vaccine (HBV) Heplisav at a German factory. The EU approval permits Dynavax to commercially produce hepatitis B surface antigen, a key component of Heplisav at the factory in Düsseldorf, in the west central part of Germany.   Rhein Biotech, a German unit of Dynavax, has used this facility to manufacture the hepatitis B surface antigen for Heplisav studies since 2006. The factory has been upgraded since then. The current EU nod comes as a result of the upgrade, thereby expanding production capacity. The new license should enable the facility to meet initial commercial production demands for the anticipated launch of the HBV vaccine. Furthermore, the upgraded facility enhances integrated product development and manufacturing services provided by the German subsidiary to third party partners.   Heplisav, Dynavax’ ...

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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