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AMAG Pharmaceuticals Inc (AMAG.OQ)

AMAG.OQ on NASDAQ Stock Exchange Global Select Market

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16 Oct 2017
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Latest Key Developments (Source: Significant Developments)

Amag Pharmaceuticals announces U.S. FDA filing acceptance
Thursday, 31 Aug 2017 08:00am EDT 

Aug 31 (Reuters) - Amag Pharmaceuticals Inc ::Amag announces U.S. FDA filing acceptance and six-month review of Feraheme® (Ferumoxytol) for the treatment of all adult patients with iron deficiency anemia.Amag Pharmaceuticals Inc - ‍prescription drug user fee act target action date of February 2, 2018 for feraheme​.  Full Article

Amag Pharmaceuticals Q2 loss per share $0.40
Thursday, 3 Aug 2017 07:02am EDT 

Aug 3 (Reuters) - Amag Pharmaceuticals Inc ::Amag pharmaceuticals announces second quarter 2017 financial results and provides corporate update.Q2 loss per share $0.40.Q2 earnings per share view $1.34 -- Thomson Reuters I/B/E/S.Q2 revenue $158.4 million versus I/B/E/S view $158.6 million.Amag pharmaceuticals inc - ‍reaffirming 2017 financial guidance​.Amag pharmaceuticals inc - sees ‍ 2017 GAAP total revenue $625 million - $685​ million.  Full Article

Amag completes feraheme FDA submission for the treatment of all adult patients with iron deficiency anemia
Thursday, 3 Aug 2017 07:00am EDT 

Aug 3 (Reuters) - Amag Pharmaceuticals Inc :Amag completes Feraheme® (ferumoxytol) FDA submission for the treatment of all adult patients with iron deficiency anemia.Amag Pharmaceuticals Inc - ‍Potential approval and launch in first half of 2018 for feraheme​.  Full Article

Amag reports U.S. FDA acceptance of supplemental new drug application for Makena
Monday, 26 Jun 2017 08:00am EDT 

June 26 (Reuters) - Amag Pharmaceuticals Inc ::Amag announces U.S. FDA filing acceptance of supplemental new drug application for makena® (hydroxyprogesterone caproate injection) subcutaneous auto-injector.Amag Pharmaceuticals Inc - prescription drug user fee act (pdufa) target action date of february 14, 2018.Amag Pharmaceuticals Inc - FDA has now determined that filing is subject to a standard 10-month review.Amag Pharmaceuticals Inc - if makena auto-injector is approved, amag will request orange book listing of eligible antares patents, last of which expires in 2026.Amag Pharmaceuticals Inc - ‍reaffirming 2017 financial guidance, including makena revenue guidance of $410 million to $440 million​.  Full Article

Camber Capital Management LLC reports 7.13 pct passive stake in AMAG Pharmaceuticals
Monday, 15 May 2017 12:38pm EDT 

May 15 (Reuters) - AMAG Pharmaceuticals Inc ::Camber Capital Management LLC reports 7.13 percent passive stake in AMAG Pharmaceuticals Inc as on May 04, 2017 - SEC filing.  Full Article

Amag Pharmaceuticals Inc says increased size of offering to $300 mln
Friday, 5 May 2017 07:00am EDT 

May 5 (Reuters) - Amag Pharmaceuticals Inc :Amag Pharmaceuticals announces pricing of $300 million of 3.25% convertible senior notes due 2022.Amag Pharmaceuticals Inc- amag has increased size of offering from originally announced $250 million.  Full Article

AMAG Pharma announces proposed offering of $250 mln of convertible senior notes due 2022
Wednesday, 3 May 2017 04:17pm EDT 

May 3 (Reuters) - AMAG Pharmaceuticals Inc :AMAG Pharmaceuticals Inc announces proposed offering of $250 million of convertible senior notes due 2022.AMAG Pharmaceuticals Inc says notes will pay interest semiannually and will mature on june 1, 2022.AMAG Pharmaceuticals Inc -intends to use net proceeds from offering of notes together with cash on hand to repay approximately $320.8 million of borrowings.AMAG Pharmaceuticals Inc says may enter into privately negotiated transactions with certain holders of its existing 2.50% convertible senior notes due 2019.  Full Article

AMAG Pharmaceuticals posts Q1 loss per share $1.06
Tuesday, 2 May 2017 07:01am EDT 

May 2 (Reuters) - AMAG Pharmaceuticals Inc :AMAG Pharmaceuticals announces first quarter 2017 financial results and provides corporate update.Q1 loss per share $1.06.Q1 earnings per share view $1.64 -- Thomson Reuters I/B/E/S.Q1 revenue $139.5 million versus I/B/E/S view $152.4 million.AMAG Pharmaceuticals Inc sees 2017 revenue between $625 million and $685 million.  Full Article

AMAG Pharmaceuticals says positive topline data from Feraheme label expansion study
Tuesday, 2 May 2017 07:00am EDT 

May 2 (Reuters) - AMAG Pharmaceuticals Inc :Announces positive topline data from phase 3 feraheme® (ferumoxytol) label expansion study.Achieved all primary and secondary safety and efficacy endpoints.On track to file SNDA mid-year with a potential approval and launch in first half of 2018.Expects to file a supplemental nda with u.s. Fda by mid-2017 to potentially broaden use of feraheme.  Full Article

Amag submits supplemental NDA for makena auto-injector
Monday, 17 Apr 2017 08:00am EDT 

April 17 (Reuters) - Amag Pharmaceuticals Inc :Amag submits supplemental new drug application to FDA for makena (hydroxyprogesterone caproate injection) auto-injector for subcutaneous use.Anticipates a six-month FDA review timeline with potential for approval and launch in Q4 of 2017.Amag Pharmaceuticals - if makena auto-injector is approved, Amag will request orange book listing of eligible antares patents, last of which expires in 2026.  Full Article

BRIEF-Amag Pharmaceuticals announces U.S. FDA filing acceptance

* Amag announces U.S. FDA filing acceptance and six-month review of Feraheme® (Ferumoxytol) for the treatment of all adult patients with iron deficiency anemia