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February 11, 2014
09:00 EDTAMAGAMAG Pharmaceuticals falls 7%
AMAG Pharmaceuticals is down 7%, or $1.48, to $19.69
News For AMAG From The Last 14 Days
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January 14, 2015
07:37 EDTAMAGJPMorgan to hold a conference
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January 11, 2015
18:25 EDTAMAGAMAG says FDA recommended label changes for Feraheme
AMAG Pharmaceuticals issued a business update and said that as part of a multi-pronged line extension/lifecycle management program for Makena, the company announced today that a preservative-free, single-dose vial for Makena has been filed and is under review at the FDA with a decision expected in Q2. Makena is currently only available in a 5-dose vial. In June 2014, AMAG proposed to the FDA certain changes to the current Feraheme label for the treatment of iron deficiency anemia in adult chronic kidney disease patients to mitigate the risk of hypersensitivity. In January 2015, the FDA responded with recommended label changes that go beyond what the company proposed in June 2014. The company plans to submit a response to the FDA's recommendations and said it will work with the FDA to finalize an updated label. AMAG added that it is awaiting feedback from the FDA regarding the study design it submitted to the FDA in 2014 to generate additional safety data to support expansion of the U.S. Feraheme label beyond the current CKD indication to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment. As announced in December 2014, AMAG will regain all worldwide development and commercialization rights for Feraheme/Rienso following the transfer of marketing authorizations. Previously, Takeda had been commercializing the product outside of the U.S. under a March 2010 license arrangement with AMAG.
18:22 EDTAMAGAMAG Pharmaceuticals sees 2015 total revenue $380M-$420M
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18:20 EDTAMAGAMAG Pharmaceuticals sees 2014 revenue $123.8M-$125.5M
Consensus $106.59M. Guidance includes approximately $14M of revenue recognized from AMAG's collaboration agreement with Takeda. AMAG says net product sales totaled between $110.1M-$111.1M. Total operating expenses for 2014 are expected to be between $104.6M-$105.9M.
18:19 EDTAMAGAMAG Pharmaceuticals sees Q4 revenue $52.8M-$54.5M
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