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AMAG Pharmaceuticals Inc (AMAG.OQ)

AMAG.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

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

Amag Pharmaceuticals, Endoceutics enter into license agreement
Tuesday, 14 Feb 2017 07:00am EST 

Amag Pharmaceuticals Inc : Amag and Endoceutics enter into an exclusive U.S. license agreement for intrarosa™ (prasterone) . Amag Pharmaceuticals Inc says "Endoceutics plans to put an additional $20 million toward supporting educational programs in 2017" . Amag Pharmaceuticals Inc- Amag expects to launch intrarosa in U.S. In mid-2017 .Amag Pharma-under terms of deal, at closing, co to pay endoceutics $50 million of total consideration, issue endoceutics 600,000 unregistered shares of co.  Full Article

Amag Pharmaceuticals enters into an agreement to develop and commercialize Rekynda
Monday, 9 Jan 2017 08:00am EST 

Amag Pharmaceuticals Inc : Entered into an agreement for exclusive North American rights to develop and commercialize Rekynda . Anticipated filing date in U.S. for NDA for Rekynda is in early 2018, with an anticipated approval and launch by early 2019 . Under terms of license agreement, Amag will pay to Palatin $60 million of total upfront consideration .To reimburse palatin for up to $25 million of ongoing development expenses incurred by Palatin related to development of Rekynda in 2017.  Full Article

Amag Pharmaceuticals qtrly loss per share $0.02
Tuesday, 9 Aug 2016 07:30am EDT 

Amag Pharmaceuticals Inc : Amag Pharmaceuticals reports second quarter 2016 financial results and provides corporate update . Qtrly loss per share $0.02 . Q2 earnings per share view $1.20, revenue view $128.5 million -- Thomson Reuters I/B/E/S . Fy2016 revenue view $533.8 million -- Thomson Reuters I/B/E/S . Total gaap quarterly product and service revenues increased approximately 50% to $127 million . Amag pharmaceuticals inc says total product and service revenue for q2 of 2016 increased approximately 50% to $127.4 million . Sees fy 2016 gaap total revenue $503 million - $553 million . Sees fy 2016 non gaap total revenue $520 - $570 million .Sees fy 2016 gaap net income $0 - $30 million ; sees fy 2016 non gaap net income $195 - $225 million.  Full Article

Amag Pharma- FDA provides manufacturing update on Makena
Friday, 22 Jul 2016 06:04am EDT 

Amag Pharmaceuticals Inc : Notified by FDA that prior approval supplement for coldstream labs approved for manufacture of preservative-free formulation of Makena .Approval provides company with an alternative manufacturer for single-dose formulation of Makena.  Full Article

AMAG Pharmaceuticals Inc gives FY 2016 guidance
Tuesday, 3 May 2016 07:00am EDT 

AMAG Pharmaceuticals Inc:Expects FY 2016 non-GAAP total product revenue of $520 - $570 million.Expects FY 2016 non-GAAP adjusted EBITDA of $255- $285 million.Expects FY 2016 non-GAAP net income of $195- $225 million.  Full Article

AMAG Pharmaceuticals Inc gives FY 2016 guidance
Wednesday, 17 Feb 2016 07:00am EST 

AMAG Pharmaceuticals Inc:Expects FY 2016 total revenue in the range of $520-$570 mln.Expects FY 2016 non-GAAP adjusted EBITDA in the range of $255- $285 mln.  Full Article

AMAG Pharmaceuticals Inc gives FY 2016 guidance
Monday, 11 Jan 2016 08:00am EST 

AMAG Pharmaceuticals Inc:Expects FY 2016 total revenue of $520 mln - $570 mln.Expects FY 2016 non-GAAP adjusted EBITDA of $255 mln - $285 mln.Expects FY 2016 non-GAAP cash earnings of $195 mln - $225 mln.  Full Article

AMAG Pharmaceuticals announces $60 million share repurchase program
Wednesday, 6 Jan 2016 08:00am EST 

AMAG Pharmaceuticals:Board of Directors has approved a share repurchase program under which AMAG may purchase up to $60 million of its common stock.  Full Article

AMAG Pharmaceuticals Inc - FDA again rejects single-dose use of AMAG's Makena - Reuters
Wednesday, 18 Nov 2015 06:45pm EST 

AMAG Pharmaceuticals Inc:AMAG Pharmaceuticals Inc said the U.S. Food and Drug Administration rejected a single dose of its hormone injection used to reduce the risk of premature birth, the agency's second rebuff in six months - RTRS.The company's shares fell 8 percent to $26.13 in after-hours trading on Wednesday - RTRS.FDA had rejected the company's application in May and requested more information on its manufacturing procedures - RTRS.The hormone injection, Makena, is currently approved and marketed in multi-dose and remains unaffected by FDA's Wednesday decision - RTRS.The multiple dose is approved to lower the risk of premature birth in pregnant women who has had one premature baby - RTRS.  Full Article

More From Around the Web

BRIEF-Amag submits supplemental NDA for makena auto-injector

* Amag submits supplemental new drug application to FDA for makena (hydroxyprogesterone caproate injection) auto-injector for subcutaneous use