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News Breaks
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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September 1, 2015
10:05 EDTAMAGOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 8point3 Energy (CAFD) initiated with an Equal Weight at Barclays... AMAG Pharmaceuticals (AMAG) initiated with an Outperform at Raymond James... Acadia (ACHC) initiated with an Outperform at Leerink... Acorda Therapeutics (ACOR) initiated with a Market Perform at Raymond James... Alexion (ALXN) initiated with a Strong Buy at Raymond James... Amedisys (AMED) initiated with an Outperform at Wells Fargo... Amgen (AMGN) initiated with a Market Perform at Raymond James... Amplify Snack Brands (BETR) initiated with a Neutral at Credit Suisse... BioMarin (BMRN) initiated with an Outperform at Raymond James... Biogen (BIIB) initiated with a Strong Buy at Raymond James... Celgene (CELG) initiated with a Strong Buy at Raymond James... CoreLogic (CLGX) initiated with a Neutral at SunTrust... Digi International (DGII) initiated with an Overweight at Stephens... First Solar (FSLR) initiated with an Overweight at Barclays... LHC Group (LHCG) initiated with an Outperform at Wells Fargo... Lancaster Colony (LANC) initiated with a Buy at BB&T... McCormick (MKC) initiated with a Buy at BB&T... NephroGenex (NRX) initiated with a Buy at H.C. Wainwright... Omega Protein (OME) initiated with a Hold at BB&T... Preferred Apartment (APTS) initiated with an Outperform at FBR Capital... Qorvo (QRVO) initiated with an Outperform at CLSA... Regeneron (REGN) initiated with an Outperform at Raymond James... Skyworks (SWKS) initiated with an Outperform at CLSA... SunPower (SPWR) initiated with an Equal Weight at Barclays... TESARO (TSRO) initiated with a Strong Buy at Raymond James... Ultragenyx (RARE) initiated with an Outperform at Raymond James... VEREIT (VER) initiated with a Buy at Goldman... Westmoreland (WLB) initiated with an Outperform at BMO Capital.
August 31, 2015
19:26 EDTAMAGAMAG Pharmaceuticals initiated with an Outperform at Raymond James
Target $75.
August 18, 2015
08:20 EDTAMAGAMAG Pharmaceuticals reinstated with a Buy at Jefferies
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