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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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 ...

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 ...

AMAG Pharmaceuticals Awaits Final FDA Decision by Month-End The US FDA will make a final decision on AMAG Pharmaceuticals Inc.'s (AMAG) anti-anemia drug Feraheme (ferumoxytol) on June 29, 2009.After a series of delays, investors will finally know if the FDA will approve AMAG's lead anti-anemia drug. Based on currently available data, we expect the straight approval of Feraheme this time by the US agency.Feraheme is an iron oxide nanoparticle which is highly bioavailable. Feraheme can be easily incorporated into hemoglobin with minimal detectable and releasable free iron. The drug candidate is intended to treat iron deficient anemia in chronic kidney disease (CKD) patients.The company filed a New Drug Application (NDA) with the FDA for the marketing approval of Feraheme on December 19, 2007. The NDA filing was accepted by the FDA in February 2008 ...

For Immediate Release

Chicago, IL - June 1, 2009 - Zacks.com releases the latest Industry Outlook. Today's interview is with senior analyst Grant Zeng, who talks about the Biotech Industry, including Myriad Genetics (MYGN), Onyx Pharmaceuticals Inc. (ONXX), AMAG Pharmaceuticals Inc. (AMAG), Dendreon (DNDN) and 3SBio Inc. (SSRX).

A synopsis of today's Industry Outlook is presented below. The full article can be read at http://at.zacks.com/?id=2678.

Our best picks at this point include Myriad Genetics (MYGN), Onyx Pharmaceuticals Inc. (ONXX) and AMAG Pharmaceuticals Inc. (AMAG), Dendreon (DNDN) and 3SBio Inc. (SSRX). We have different reasons for a BUY rating for each of the four companies, but all of these companies have one thing in common -- strong balance sheets, which eliminates immediate financing needs.

Both MYGN

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OVERVIEWThe Biotech industry as a whole continues to underperform the market so far this year. As of May 26, 2009, Both the AMEX Biotech Index and the broader NASDAQ Biotech Index declined 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies), while the Dow Jones Biotech Index declined 3% (which includes 33 companies).At the same time, both the NASDAQ Composite and S&P 500 have achieved positive returns. NASDAQ has made a gain of 11% as of 5/26/09 and the S&P 500 has gained 0.8%, while the Dow Jones Industrials reached a negative 3.5% return.This constitutes a sharp contrast with last year when the Biotech industry as a whole achieved much better performance than the market. In 2008, all three biotech indices outperformed all three major market indices by a large margin. The three major indices declined ...

AMAG Pharmaceutical's Feraheme Close to Approval AMAG Pharmaceuticals, Inc. (AMAG) reported first quarter 2009 financial resorts and recent accomplishments Thursday after market close.Apparently, investors are not interested in its financial results; instead, they are more focused on the approval status of the company's lead anti-anemia drug Feraheme. In the news release and the conference call, the company disclosed that all outstanding issues pertaining to the manufacturing of Feraheme have been settled to the satisfaction of the FDA, and that a re-inspection of its manufacturing facility will not be required as a condition to approval of Feraheme.Put another way -- the approval of Feraheme is very close. We estimate a final decision from the FDA by the middle of this year.As a reminder, Feraheme (formerly called Ferumoxytol) is AMAG's lead anti-anemia drug candidate. The company filed a New Drug Application (NDA) ...

FDA Approval of Ferumoxytol Expected Mid-2009AMAG Pharmaceuticals Inc.'s (AMAG) lead drug candidate Ferumoxytol (Feraheme) is under the FDA review. The company received two approvable letters in October and December 2008 respectively.However, good news is that the letters did not ask for additional clinical trials. Instead, the agency only requested data related to chemistry, manufacturing and controls (CMC) questions and labeling issues.Specifically, in the second approvable letter, the agency indicated that the following additional information is required prior to granting approval of ferumoxytol: Data to clarify a specific chemistry, manufacturing and controls (CMC) question; resolution of the deficiencies observed during the pre-approval inspection of the Company's manufacturing facility; and finalization of labeling discussions with the FDA.The company has provided a response to the FDA regarding the CMC question, and is in active dialogue to resolve the outstanding manufacturing issues. We believe ...

Emerging Biotech & Pharma Index: 36 More Cos. The accompanying table [click to enlarge or download] includes the 36 remaining companies in the ETF Innovators [ETFI] Emerging Bio-Pharma Index with market caps between $150M-$1.5B, which were not included in the previous two articles I wrote about the group – featuring the Top 40 Rated Companies and companies below the $150M market cap cutoff. However, several of the companies included in the remaining group of 36 have been in the news recently due to FDA related news. Late last week, Ligand Pharma (LGND) received approval along with its collaboration partner Glaxo (GSK) for Promacta while Theravance (THRX) received a positive panel review for its antibiotic telavancin. Previously, ...