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December 10, 2012
11:22 EDTAMAGAMAG says ferumoxytol met both primary endpoints in two trials
AMAG said in trial IDA-301 the primary efficacy endpoint for U.S. regulators is the proportion of subjects who achieved a 2.0 g/dL increase in hemoglobin at any time from baseline to week 5; the primary efficacy endpoint for European Union regulators is the mean change in hemoglobin from baseline to week 5. In the IDA-301 trial, ferumoxytol achieved both primary efficacy endpoints. In IDA-302 the same primary efficacy endpoints were used and in the IDA-302 trial, ferumoxytol achieved both primary efficacy endpoints. In IDA-301, the overall rate of reported adverse events was higher in the ferumoxytol group than in the placebo group, although no new safety signals, outside of those described in the current Feraheme label, were observed in this study. In the IDA-302 trial, the overall rates of adverse events and related adverse events were comparable in ferumoxytol- and iron sucrose-treated subjects, and included many attributable to comorbid disease. However, the overall rate of SAEs, both related and unrelated as assessed by the investigator, was higher in ferumoxytol-treated subjects.
News For AMAG From The Last 14 Days
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July 30, 2015
20:03 EDTAMAGAMAG Pharmaceuticals 3.15M share Secondary priced at $63.75
Jefferies and Barclays acted as joint book running managers for the offering.
08:29 EDTAMAGAMAG says 'additional insight' gained into FTC investigation
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08:26 EDTAMAGAMAG capital raise removes overhang, says Leerink
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July 29, 2015
17:15 EDTAMAGAMAG Pharmaceuticals announces proposed offering of $200M of common stock
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July 23, 2015
09:13 EDTAMAGOn The Fly: Pre-market Movers
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07:25 EDTAMAGAMAG affirms FY15 revenue view $395M-$430M, consensus $465.45M
Raises FY15 adjusted EBITDA guidance view to $210M-$225M from $200M-$220M.
07:23 EDTAMAGAMAG reports Q2 adjusted EPS $1.12, one estimate $1.13
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July 22, 2015
16:10 EDTAMAGAMAG acquires option for rights to Velo Bio's digoxin immune fab
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