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AMAG Pharmaceuticals (AMAG) has received FDA notification that the Agency is proposing to withdraw approval of Makena (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth.The FDA also notif...
The product remains on the market AMAG has 15 days to respond to the FDA AMAG continues to expect its recently announced tender offer and merger to close in November 2020 WALTHAM, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, ...
In a not-unexpected move, the FDA is proposing that AMAG Pharmaceuticals' ([[AMAG]] -6.0%) Makena (hydroxyprogesterone caproate injection), approved in the U.S. in February 2011 to reduce the risk of preterm birth in at-risk pregnant women, be removed from the market due to lack of efficacy.A...
Gainers: Solid Biosciences (SLDB) +114%.Enlivex Therapeutics (ENLV) +45%.AMAG Pharmaceuticals (AMAG) +45%.American Equity Investment Life (AEL) +40%.Gridsum (GSUM) +36%.Bed Bath & Beyond (BBBY) +33%.Watford Holdings (WTRE) +26%.Advanced Emissions Solutions (ADES) +25%.Westwater Resou...
Shares of AMAG Pharmaceuticals (NASDAQ: AMAG) were skyrocketing 44.6% higher as of 11:10 a.m. EDT on Thursday. The huge jump began Thursday morning after Bloomberg reported that Covis Pharma, a drugmaker backed by Apollo Global Management (NYSE: APO) , is in talks to acquire...
Gainers: Solid Biosciences (SLDB) +121%, Enlivex Therapeutics (ENLV) +49%, AMAG Pharmaceuticals (AMAG) +45%, ProPhase Labs (PRPH) +14%, Odonate Therapeutics (ODT) +14%.Losers: Zosano Pharma (ZSAN) -54%, LogicBio Therapeutics (LOGC) -...
Apollo Global Management portfolio company Covis Group S.à r.l. has agreed to acquire AMAG Pharmaceuticals ([[AMAG]] +43.9%) for $13.75 per share in cash. The total transaction value is ~$498M on a fully diluted basis or ~$647M on an enterprise basis including debt.The tender offer for A...
Addition of AMAG’s category leading treatments positions Covis to become a global market leader of therapeutic solutions for life-threatening conditions and chronic illnesses Covis will commence a tender offer to acquire all the outstanding shares of AMAG for ...
Enlivex Therapeutics (ENLV) +103% on positive Allocetra results in COVID-19.Solid Biosciences (SLDB) +77% in reaction to the FDA's removal of the clinical hold placed on its Phase 1/2 clinical trial.American Equity Investment Life Holding (AEL) +57% on ~$3B takeo...
Gainers: [[AMAG]] +39.4%. [[DNOW]] +9.9%. [[DTIL]] +5.5% [[MNOV]] +5.0%. [[ODT]] +4.5%.Losers: [[LOGC]] -25.1%. [[SPI]] -15.6%. [[AMBO]] -5.9%. [[NG]] -5.9%. [[cc]] -4.3%. For further details see: AMAG, ODT, SPI and NG among after-hours movers
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WALTHAM, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. has submitted its response to the FDA’s Notice of Opportunity for a Hearing (“NOOH”) regarding the Agency’s proposal to withdraw approval for Makena—also referred to as 17-OHP...
MGIC Investment & Halozyme Therapeutics Set to Join S&P MidCap 400; First Bancorp, The Geo Group & Mednax to Join S&P SmallCap 600 MGIC Investment & Halozyme Therapeutics Set to Join S&P MidCap 400; First Bancorp, The Geo Group & Mednax to Join S&...
WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena ® , the only F...