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AMAG Pharmaceuticals Inc (AMAG.O)

AMAG.O on Nasdaq

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26 Jun 2019
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Latest Key Developments (Source: Significant Developments)

Palatin Technologies Says FDA Approves NDA For Vyleesi
Friday, 21 Jun 2019 05:40pm EDT 

June 21 (Reuters) - AMAG Pharmaceuticals Inc ::PALATIN TECHNOLOGIES - FDA APPROVAL OF NDA FOR VYLEESI TRIGGERS $60 MILLION MILESTONE PAYMENT TO CO UNDER ITS NORTH AMERICAN LICENSE AGREEMENT WITH AMAG.  Full Article

FDA Approves New Treatment For Hypoactive Sexual Desire Disorder In Premenopausal Women
Friday, 21 Jun 2019 05:13pm EDT 

June 21 (Reuters) - AMAG Pharmaceuticals Inc ::FDA APPROVES NEW TREATMENT FOR HYPOACTIVE SEXUAL DESIRE DISORDER IN PREMENOPAUSAL WOMEN.U.S. FDA - APPROVED VYLEESI (BREMELANOTIDE) TO TREAT ACQUIRED, GENERALIZED HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) IN PREMENOPAUSAL WOMEN.U.S. FDA - GRANTED APPROVAL OF VYLEESI TO AMAG PHARMACEUTICALS.  Full Article

AMAG Pharmaceuticals Posts Q1 Revenue of $75.8 Million
Tuesday, 7 May 2019 07:01am EDT 

May 7 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2019 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q1 LOSS PER SHARE $3.54 FROM CONTINUING OPERATIONS.Q1 REVENUE $75.8 MILLION VERSUS REFINITIV IBES ESTIMATE OF $90.1 MILLION.Q1 EARNINGS PER SHARE ESTIMATE $-0.26 -- REFINITIV IBES DATA.SEES Q1 2019 REVENUE $75.8 MILLION.REAFFIRMED 2019 FINANCIAL GUIDANCE.AS OF MARCH 31, 2019, COMPANY'S CASH AND INVESTMENTS TOTALED $266.5 MILLION, AND LONG-TERM TOTAL DEBT TOTALED $320.0 MILLION.  Full Article

AMAG Pharmaceuticals Inc - Combining Its Women's And Maternal Health Sales Forces Into One Integrated Sales Team
Thursday, 7 Feb 2019 07:53am EST 

Feb 7 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS INC - IT WAS COMBINING ITS WOMEN'S AND MATERNAL HEALTH SALES FORCES INTO ONE INTEGRATED SALES TEAM.AMAG PHARMACEUTICALS INC - COMPANY WILL REDUCE ITS OVERALL HEADCOUNT BY APPROXIMATELY 110 EMPLOYEES.AMAG PHARMACEUTICALS INC - WORKFORCE REDUCTION IS EXPECTED TO BE SUBSTANTIALLY COMPLETED IN Q1 OF 2019.AMAG PHARMACEUTICALS-EXPECTS TO RECORD RESTRUCTURING CHARGES, INCUR FUTURE CASH EXPENDITURES TOTALING ABOUT $6.0 MILLION IN CONNECTION WITH WORKFORCE REDUCTION.  Full Article

Slayback Pharma Launches Hydroxyprogesterone Caproate Injection, Generic Equivalent Of Makena Injection
Monday, 21 Jan 2019 01:45pm EST 

Jan 21 (Reuters) - Slayback Pharma LLC::SLAYBACK PHARMA ANNOUNCES LAUNCH OF HYDROXYPROGESTERONE CAPROATE INJECTION, USP 1,250 MG/ 5 ML IN A MULTI-DOSE VIAL, THE FIRST GENERIC EQUIVALENT OF MAKENA® INJECTION 1,250 MG/ 5 ML MULTI-DOSE VIAL.SLAYBACK PHARMA LLC SAYS MAKENA IS A REGISTERED TRADEMARK OF AMAG PHARMACEUTICALS.  Full Article

AMAG Pharmaceuticals Pays Off $475 Million Of Senior Secured Notes
Thursday, 6 Sep 2018 08:00am EDT 

Sept 6 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS PAYS OFF $475 MILLION OF SENIOR SECURED NOTES.AMAG PHARMACEUTICALS INC - REDEEMED $475 MILLION OF ITS OUTSTANDING 7.875% SENIOR NOTES, USING PROCEEDS FROM SALE OF CORD BLOOD REGISTRY.  Full Article

Palatin Technologies Receives FDA Acceptance For Review Of Bremelanotide NDA
Monday, 4 Jun 2018 07:11am EDT 

June 4 (Reuters) - Palatin Technologies Inc ::PALATIN TECHNOLOGIES ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF BREMELANOTIDE NDA.PALATIN TECHNOLOGIES ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF BREMELANOTIDE NDA.PALATIN TECHNOLOGIES INC - PDUFA GOAL DATE FOR COMPLETION OF FDA REVIEW OF BREMELANOTIDE NDA IS MARCH 23, 2019.PALATIN TECHNOLOGIES - FDA'S ACCEPTANCE OF NDA TRIGGERS $20 MILLION MILESTONE PAYMENT TO CO UNDER ITS LICENSE AGREEMENT WITH AMAG PHARMACEUTICALS.  Full Article

AMAG Pharmaceuticals and Sandoz Enters Stipulation Of Dismissal
Friday, 23 Mar 2018 08:32am EDT 

March 23 (Reuters) - Amag Pharmaceuticals Inc ::AMAG PHARMACEUTICALS - ‍CO, SANDOZ ENTERED STIPULATION OF DISMISSAL, PURSUANT TO SETTLEMENT AGREEMENT, THAT DISMISSES, RESOLVES PATENT LITIGATION​.AMAG PHARMACEUTICALS - ‍SETTLEMENT DISMISSES & RESOLVES PATENT LITIGATION RELATED TO CO'S FERAHEME, 30 MG/ML, 17 ML SINGLE DOSE VIALS FOR INTRAVENOUS USE​.AMAG PHARMACEUTICALS - ‍IF SANDOZ RECEIVES FDA APPROVAL BY A CERTAIN DATE, SANDOZ MAY LAUNCH GENERIC VERSION OF FERAHEME ON JULY 15, 2021, OR EARLIER​.AMAG PHARMACEUTICALS - ‍SANDOZ TO PAY SALES ROYALTY OF GENERIC VERSION OF FERAHEME TO AMAG UNTIL EXPIRATION OF LAST FERAHEME PATENT LISTED IN ORANGE BOOK​.  Full Article

AMAG Reports Q4 Earnings Of $0.10 Per Share
Tuesday, 27 Feb 2018 07:00am EST 

Feb 27 (Reuters) - Amag Pharmaceuticals Inc ::AMAG REPORTS 2017 FINANCIAL RESULTS AND COMPANY UPDATE.Q4 EARNINGS PER SHARE $0.10.TOTAL GAAP REVENUES FOR Q4 OF 2017 WERE $158.3 MILLION, COMPARED WITH $151.6 MILLION.NON-GAAP REVENUE TOTALED $159.7 MILLION IN Q4 OF 2017, UP FROM $153.0 MILLION.SAYS AFFIRMS FINANCIAL GUIDANCE FOR 2018.QUARTERLY TOTAL REVENUES $158.3 MILLION VERSUS $151.6 MILLION.  Full Article

AMAG Gets FDA Approval Of Makena Subcutaneous Auto-Injector
Wednesday, 14 Feb 2018 06:03pm EST 

Feb 14 (Reuters) - Amag Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF MAKENA® (HYDROXYPROGESTERONE CAPROATE INJECTION) SUBCUTANEOUS AUTO-INJECTOR TO REDUCE THE RISK OF PRETERM BIRTH IN CERTAIN AT-RISK WOMEN.AMAG PHARMACEUTICALS - EXPECTS TO FILE A NEW DRUG APPLICATION THIS QUARTER FOR A NEW CHEMICAL ENTITY (BREMELANOTIDE) ​.AMAG PHARMACEUTICALS INC - ‍EXPECTS SUBCUTANEOUS AUTO-INJECTOR TO BE AVAILABLE IN SECOND HALF OF MARCH​.AMAG PHARMACEUTICALS INC - WILL CONTINUE TO OFFER IM FORMULATION OF MAKENA IN BOTH SINGLE-DOSE AND MULTI-DOSE VIALS​.AMAG PHARMACEUTICALS INC - ‍MAKEN'S 7-YEAR ORPHAN DRUG EXCLUSIVITY EXPIRED EARLIER THIS MONTH​.AMAG PHARMACEUTICALS - ANNOUNCES FDA APPROVAL OF MAKENA (HYDROXYPROGESTERONE CAPROATE INJECTION) SUBCUTANEOUS AUTO-INJECTOR ‍​.  Full Article

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FDA approves drug for loss of sexual desire in women

The U.S. drug regulator on Friday approved Palatin Technologies and Amag Pharmaceuticals' drug to restore sexual desire in premenopausal women, the latest attempt to come up with a therapy that some have dubbed as "female Viagra".