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Rockwell Medical (NASDAQ:RMTI): Early-Stage AMAG Growth Potential

Wed, 02 Sep 2009 16:43:00 GMT

Rockwell Medical (NASDAQ:RMTI) has the potential for significant stock price gains by 2012 based on the enhanced earnings power of at least $4/share at that time for its lead clinical compound Soluble Ferric Pyrophosphate (SFP) with just a 20% share of the estimated $600 million U.S. market for iron replacements in 2012.[More...]

Post Market Report: Wall Street Gains On Economic Optimism, Kraft Foods (NYSE: KFT) Jumps

Wed, 01 Jul 2009 23:02:43 GMT

US stocks finished higher on Wednesday after better-than-expected manufacturing and housing data lifted optimism.[More...]

US Stocks Poised To Open Higher, Economic Data In Spotlight

Wed, 01 Jul 2009 12:55:00 GMT

US stock futures pointed to higher start on Wednesday ahead of key economic data. Stocks trimmed some of the gains after weaker than expected ADP jobs data.[More...]

FDA Calendar Updates: Feraheme Approval For AMAG

Wed, 01 Jul 2009 01:52:13 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response lette (...)[More...]

FDA Calendar Updates: AMAG, PPDI, Takeda

Tue, 30 Jun 2009 00:39:42 GMT

BioMedReports FDA Calendar: 19 Hot Summer Trades

Wed, 17 Jun 2009 12:13:04 GMT

Below is a sample of entries from the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The companies outlined below have expected FDA new drug product decisions or clinical trial results expected over the next three months of summer. The list also includes some Extreme Trades of companies with market caps below $250 million that have pending clinical trial results or FDA decisions that could have a major stock price impact. Rigel Pharma (NASDAQ:RIGL): On 5/5/09, (...)[More...]

Biotech Industry Overview

Mon, 01 Jun 2009 14:38:59 GMT

The 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 inc[More...]

FDA Calendar Updates: AMAG Pharma (Nasdaq: AMAG), Northfield Labs (NASDAQ:NFLD)

Fri, 01 May 2009 04:29:49 GMT

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA (...)[More...]

Biotech Industry - Industry Outlook

Thu, 16 Apr 2009 20:54:01 GMT

Last year, the Biotech industry as a whole achieved a much better performance than the market. Both the NASDAQ Biotech Index and AMEX Biotech Index outperformed all three major market indices (Dow Jones Industrial Average, NASDAQ Composite and S&P 500) in a large margin. The major indices declined as much as 40% while the NASDAQ Biotech Index declined only 12.6% and the AMEX Biotech Index was down 17.7%. However, when the recession enters into its third year, the Biotech industry is not doing better than the market, which has been evident by the indices' performances. As of April 9, 2009, AMEX Biotech Index declined 3%, and the broader NASDAQ Biotech Index was down 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies). Although the Dow and S&P 500 also declined a similar percentage, technology-laden NASDAQ actually has a gain of 4.8%, which is more comparable to the biotech indices. See[More...]

AMAG Pharma: High Expectations - Analyst Blog

Tue, 20 Jan 2009 20:15:00 GMT

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 (New Drug Application) for its lead drug, Ferumoxytol, in December 2007, and we expect FDA approval to come in 1H09. Clinical data in over 1,700 patients indicate an excellent safety profile for the drug with lower incidents of heart problems. Clinical results, and eventual approval for additional indications, should ensure strong growth in the coming years. We maintain our Buy rating on the shares of AMAG with a target price of $55. Read the full[More...]

Analyst Picks and Pans: QLGC, AMCC, AMAG

Mon, 04 May 2009 14:56:00 GMT

Needham analyst Glenn Hanus said on May 1 that QLogic posted $0.20 fourth-quarter non-GAAP EPS vs. the $0.21 that he expected.
Hanus downgraded the shares as QLogic approaches his target, M&A speculation been contributing to valuation, and fiscal 2011 results are difficult to forecast.
Oppenheimer analyst Dan Morris said on May 1 that AMCC's $0.18 fourth-quarter non-GAAP loss per share [including results from its divested 3Ware business] compares with Wall Street's $0.12 loss estimate.

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AMAG Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter Ended September 30, 2009

Thu, 29 Oct 2009 11:46:00 GMT

The Company commenced the U.S. commercial launch of Feraheme (ferumoxytol) Injection on July 13, 2009, within two weeks of receipt of FDA approval.
The Company reported $3.0 million of total revenues for the third quarter of 2009, of which $2.9 million was related to the sale of Feraheme.
An additional $11.5 million was recorded as deferred revenue as of September 30, 2009.

[More...]

AMAG Pharmaceuticals, Inc. to Present at the Canaccord Adams 29th Annual Global Growth Conference

Tue, 04 Aug 2009 20:07:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Brian J.G. Pereira, MD, President and Chief Executive Officer, will present an overview of the Company at the Canaccord Adams 29th Annual Global Growth Conference on Tuesday, August 11 at 9:00 a.m. ET. The conference is being held August 11-13, 2009 in Boston, MA.[More...]

AMAG Pharmaceuticals, Inc. Reports Financial Results for the Quarter Ended June 30, 2009

Wed, 29 Jul 2009 20:06:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the quarter and six months ended June 30, 2009.[More...]

AMAG Pharmaceuticals, Inc. to Host Conference Call to Discuss Financial Results for the Quarter Ended June 30, 2009

Wed, 22 Jul 2009 21:16:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced it will report unaudited consolidated financial results for the quarter ended June 30, 2009 after the U.S. financial markets close on July 29, 2009. The announcement will be followed by a conference call at 4:30 p.m. ET during which management will discuss the Company’s financial results, business highlights and its development programs.[More...]

AMAG Pharmaceuticals Announces U.S. Launch of Feraheme™ (ferumoxytol) Injection

Mon, 13 Jul 2009 20:29:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Feraheme™ (ferumoxytol) Injection is now available for commercial sale in the United States. Feraheme is an intravenous (IV) iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme can provide patients with a 1 gram therapeutic course of iron in two 510 mg IV injections administered as quickly as 17 seconds each, within one week. Feraheme was approved by the U.S. Food and Drug Administration on June 30, 2009.[More...]

FDA Approves Feraheme™ to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients

Tue, 30 Jun 2009 20:40:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for 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 recommended dose of Feraheme is an initial 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.[More...]

FDA Decision on Feraheme NDA Expected Within Next Few Days

Mon, 29 Jun 2009 22:46:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has not received an action letter from the U.S. Food and Drug Administration (FDA) for Feraheme™ (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease patients. The Prescription Drug User Fee Act (PDUFA) action date was today, June 29, 2009. The FDA informed the Company that the Agency would not take action today, but expects to issue an action letter within the next few days. The FDA has not requested any additional information from the Company, and it is the Company’s understanding that there are no outstanding issues regarding the Feraheme New Drug Application.[More...]

AMAG Pharmaceuticals, Inc. to Present at the Jefferies Third Annual Healthcare Conference

Fri, 12 Jun 2009 13:03:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Brian J.G. Pereira, MD, President and Chief Executive Officer, will present an overview of the Company at the Jefferies Third Annual Healthcare Conference on June 18, 2009 at 1:00 p.m. ET. The conference is being held in New York City.[More...]

AMAG Pharmaceuticals Announces Appointment of Ricardo Zayas as Senior Vice President of Operations

Mon, 08 Jun 2009 20:03:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on treating iron deficiency anemia and developing novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today announced that Ricardo Zayas has been appointed Senior Vice President of Operations. Mr. Zayas brings over two decades of pharmaceutical operations and commercial manufacturing experience to the Company. In his new position with AMAG, Mr. Zayas will be responsible for leading the Company’s manufacturing, materials management, quality assurance, quality control, and supply chain functions and will report directly to Brian J.G. Pereira, MD, President and CEO.[More...]

AMAG Pharmaceuticals, Inc. to Present at the Eighth Annual Needham Life Sciences Conference

Thu, 04 Jun 2009 12:33:00 GMT

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Brian J.G. Pereira, MD, President and Chief Executive Officer, will present an overview of the Company at the Eighth Annual Needham Life Sciences Conference on June 11, 2009 at 10:00 a.m. ET. The conference is being held in New York City.[More...]