AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG)
The Company is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products.
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Poor Forward Earnings Estimate
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vannamonde
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Depressed job market, debt laden consumers, rising tax burdens, corporate real estate, credit card defaults, and especially housing starts. The latter typically leads normal recoveries.
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vanamonde and porte pick at end of selloff
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pharmacuticals will rule the stock market for awhile
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Yes we are playing speculativ here, but reward should be substantial if the FDA press the green on this one.
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$64.60
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AMAG has a good short term current asset position. Cash or liquidty will be needed for several months since it has been experiencing quarterly losses as sales continue to be soft. Negative cash flow will place some stress here. This may change abruptly once the Anemia Drug is approved by the FDA. The question is WHEN? It's evident that a deep slide on the stock price will be buffered by the confidence exhibited by the Officers of the company at prices levels of $28 or lower. Above $34 is another story.
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An A-List of Stock Buys: Altria and AMAG Pharma
http://www.etfinnovators.com/2008/12/a-list-of-stock-buys-altria-and-amag.html
On my stock A-List of stock buys today are defensive picks from tobacco and healthcare, including Altria (MO) and AMAG Pharma (AMAG).
Altria was well on its way to 16 bucks today on an analyst upgrade until the Supreme Court ruled that tobacco companies could be sued for deceptive marketing practices for light cigarettes. Altria believes the litigation is manageable and the Company noted that the ruling today simply allows the lawsuits to proceed and does not reflect a decision of liability against MO in the cases.
I bought more shares of Altria today at 15 bucks with an 8.5% dividend yield and with the potential for legislation [web link to full text of H.R. 1108] next year which would place tobacco products under FDA regulation. Regulation by the FDA would ensure the following bullish conditions for MO, which already dominates the U.S. market for tobacco products and will close on its acquisition of smokeless tobacco maker UST Inc. (UST) early next year: cigarettes would never be banned, new tobacco products would likely never be approved, advertising would be further restricted, and the FDA would take a tougher stance on the sale of counterfeit tobacco products.
I also bought AMAG Pharma today at 32 bucks ahead of an expected FDA decision before year-end with a PDUFA date of 12/30/08 for the Company's pending new drug application for ferumoxytol as a treatment for iron-deficiency anemia in patients with chronic kidney disease. In mid-November, AMAG bounced nicely off its 52-week lows in the high teens back to the thirties on word that the FDA accepted its complete response for the drug and designated the submission for a Class I review of 60 days.
The Class I designation by the FDA removed any risk of costly and time-consuming delays for AMAG to conduct additional clinical trials and improves the odds for approval by the agency. With AMAG still down by about 50% in the past year, over 14 bucks per share in cash + investments ($241M), zero debt, and only 17M shares outstanding; the stock is poised for a major pop if it gets the FDA okay for ferumoxytol.
AMAG is ready to launch the drug quickly in 1Q09 if it is approved and will be working closely with dialysis providers such as DaVita (DVA) as a major source of patients with chronic kidney disease who would be candidates for ferumoxytol. AMAG could easily return to the sixties with a clean, on-time FDA approval before year-end, which is around consensus analyst price targets and the 52-week high of just under 67 bucks.
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On May 31st, AMAG Pharmaceutical announced results from a randomized phase III study of Ferumoxytol, an intravenous (IV) iron replacement therapy, in 31 patients with chronic kidney disease (CKD) stages 1-5 with functioning kidney transplants. The primary endpoint was the mean change in hemoglobin from baseline at Day 35. more at http://biotechnology-stock.blogspot.com/search/label/AMAG
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Deal with China. I bought here. Mistake? not sure but seems hopeful that things are moving in right direction.
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oversold, riding it back up.....
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hot new drug in pipeline
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drug about to be approved
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Next big thing, has really sold off.
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On a strictly technical basis, my magic charts say this will outperform the S&P
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Nanoparticles, therapeutic iron and MRI's... OH MY
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Bought into this at 32 USD (bought at 12 USD in real life). I expect this to be bought out by someone as FDA approvals near. EXpect to run to 75 USD or so
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FDA approval of thier product, Combidex, should occur in the next year and may well revolutionize Magnetic Resonance imaging, especially for cancer patients.
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Advanced Magnetics is focused on the development and commercialization of its nanoparticles technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. It has two approved products, Feridex intravenous (IV) and GastroMARK, and two product candidates, Ferumoxytol and Combidex.
Ferumoxytol is a key product in Phase III multi-center clinical trials for use as an IV iron replacement therapeutic in chronic kidney disease patients. The company plans to submit the NDA for ferumoxytol to the US FDA, during mid 2007 and an immediate commercial launch. Combidex, an investigational molecular imaging agent consisting of iron oxide nanoparticles, is used to aid in the differentiation of cancerous from normal lymph nodes. The company plans to respond to the March 2005 US FDA conditional approval letter for Combidex, in early 2007. Both these drugs do not face a strong competition in the US and European markets.
For the three months ended December 2006, the companys revenues decreased 7% to $619,000 reflecting a decrease in product and licensing revenues, received from its marketing partners, for the sale of Feridex I.V. and GastroMARK, as a result of unpredictable annual demand from end users. Royalties also reduced by 7% due to decrease in sale of Feridex IV and GastroMARK. However, it ended the quarter with $114 million of cash in its kitty, sufficient to satisfy its future cash flow needs.
The company looks like a cash rich attractive investment opportunity as it expects to recover its product, license and royalty revenues on the back of commercial launch of Ferumoxytol and improving sales of Feridex IV and GastroMARK.
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