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December 10, 2012
11:18 EDTAMAGAMAG Pharmaceuticals announces new data from phase III trials of ferumoxytol
AMAG Pharmaceuticals announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology’s annual meeting in Atlanta, Georgia. The phase III trials evaluated the use of ferumoxytol in subjects with iron deficiency anemia, or IDA, regardless of the underlying cause of the anemia, who had failed or could not tolerate oral iron treatment. New data from an investigator-initiated study evaluating a one gram 15-minute infusion of ferumoxytol are also being presented at ASH; the current approved dosing of ferumoxytol is two 510 mg injections, three to eight days apart. Two poster sessions highlighted the safety and efficacy data from each of the phase III clinical trials: IDA-301 and IDA-302. In addition, an oral presentation contained patient-reported outcome data from IDA-301, which demonstrated a direct correlation between the rise in hemoglobin and improvement in patient-reported measures of fatigue. Data from these two clinical trials will be the foundation for AMAG’s supplemental new drug application in the United States. AMAG's sNDA will seek to expand the use of Feraheme for all adult iron deficiency anemia patients with a history of unsatisfactory use of oral iron. The company expects to submit the sNDA to the U.S. Food and Drug Administration this month. In the United States, Feraheme is currently indicated only for the treatment of iron deficiency anemia in adult CKD patients.
News For AMAG From The Last 14 Days
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June 29, 2015
12:10 EDTAMAGAMAG acquisition of Cord Blood Registry a strong fit, says Leerink
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07:39 EDTAMAGAMAG Pharmaceuticals to host conference call
Conference call to discuss acquisition of Cord Blood Registry will be held on June 29 at 8 am. Webcast Link
07:02 EDTAMAGAMAG Pharmaceuticals to acquire Cord Blood Registry for $700M
AMAG Pharmaceuticals announced that it has entered into a definitive agreement to acquire Cord Blood Registry, or CBR, the world's largest stem cell collection and storage company serving pregnant women and their families, for $700M. The acquisition of CBR would expand AMAG's suite of maternal health offerings and add a high-margin business with complementary commercial capabilities and attractive future growth opportunities to the AMAG portfolio. The transaction is expected to further diversify AMAG's revenue base, be immediately accretive to adjusted EBITDA and earnings, and result in expense synergies of approximately $15M annually. CBR's revenue consists of upfront processing revenues for newly stored units, as well as a high-margin recurring revenue based on cumulative stored units. CBR's growing base of installed units provides for an increasing mix of revenue from storage fees. The larger and more diversified forecasted revenues that we expect as a result of this transaction are projected to allow AMAG to achieve a lower overall cost of capital, with terms that provide more flexibility and borrowing capacity to consummate future transactions. The transaction has been unanimously approved by AMAG's and CBR's boards. It is anticipated that the transaction will close in Q3.

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