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AMAG Pharmaceuticals Inc (AMAG.OQ)

AMAG.OQ on NASDAQ Stock Exchange Global Select Market

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18 Jan 2019
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Latest Key Developments (Source: Significant Developments)

Palatin Technologies Say FDA Has Extended Prescription Drug User Fee Act Date For Vyleesi By Three Months
Monday, 7 Jan 2019 

Jan 7 (Reuters) - AMAG Pharmaceuticals Inc ::PALATIN TECHNOLOGIES - FDA HAS EXTENDED THE PRESCRIPTION DRUG USER FEE ACT DATE FOR VYLEESI BY THREE MONTHS TO JUNE 23, 2019..PALATIN TECHNOLOGIES - FDA-REQUESTED FREQUENT-DOSING STUDY WITH PREMENOPAUSAL VOLUNTEERS ASSESSING SHORT TERM DAILY USE OF VYLEESI HAS BEEN INITIATED.PALATIN TECHNOLOGIES INC - STUDY RESULTS ARE ANTICIPATED TO BE SUBMITTED TO THE FDA PRIOR TO THE UPDATED PDUFA DATE OF JUNE 23, 2019..  Full Article

AMAG Pharmaceuticals Announces Preliminary 2018 Results
Monday, 7 Jan 2019 

Jan 7 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ANNOUNCES PRELIMINARY 2018 FINANCIAL RESULTS AND PROVIDES 2019 FINANCIAL GUIDANCE.SEES FY 2018 REVENUE $471 MILLION TO $476 MILLION.SEES Q4 2018 REVENUE $85 MILLION TO $90 MILLION.FY2018 REVENUE VIEW $491.3 MILLION -- REFINITIV IBES DATA.Q4 REVENUE VIEW $101.8 MILLION -- REFINITIV IBES DATA.  Full Article

AMAG Pharmaceuticals Says Under Deal With Perosphere, The Company Is Obligated To Pay Future Contingent Consideration Of Up To $365 Mln
Thursday, 13 Dec 2018 

Dec 13 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS INC - UNDER DEAL WITH PEROSPHERE, THE COMPANY IS OBLIGATED TO PAY FUTURE CONTINGENT CONSIDERATION OF UP TO $365 MILLION.AMAG PHARMACEUTICALS INC - COMPANY INTENDS TO FUND THE UPFRONT MERGER CONSIDERATION FROM CASH ON HAND..  Full Article

AMAG Pharmaceuticals To Acquire Perosphere Pharmaceuticals
Thursday, 13 Dec 2018 

Dec 13 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ENTERS INTO DEFINITIVE MERGER AGREEMENT TO ACQUIRE PEROSPHERE PHARMACEUTICALS.AMAG PHARMACEUTICALS INC - AMAG WILL PAY PEROSPHERE EQUITYHOLDERS $50 MILLION.AMAG PHARMACEUTICALS INC - AMAG WILL ASSUME $12 MILLION UNDER A TERM LOAN AND UP TO $6.2 MILLION OF PEROSPHERE'S OTHER LIABILITIES.AMAG PHARMACEUTICALS INC - CIRAPARANTAG HAS BEEN WELL TOLERATED IN CLINICAL TRIALS.AMAG PHARMACEUTICALS INC - PEROSPHERE EQUITYHOLDERS WILL BE ELIGIBLE TO RECEIVE REGULATORY MILESTONES OF UP TO $140 MILLION.AMAG PHARMACEUTICALS INC - PEROSPHERE EQUITYHOLDERS ARE ALSO ELIGIBLE TO RECEIVE COMMERCIAL SALES MILESTONE PAYMENTS OF UP TO AN AGGREGATE OF $225 MILLION.AMAG PHARMACEUTICALS INC - FIRST COMMERCIAL SALES MILESTONE PAYMENT OF $20 MILLION WOULD BE PAYABLE UPON ACHIEVING ANNUAL NET SALES OF $100 MILLION.AMAG PHARMACEUTICALS INC - PEROSPHERE EQUITYHOLDERS ARE ALSO ELIGIBLE TO RECEIVE COMMERCIAL SALES MILESTONE PAYMENTS OF UP TO AN AGGREGATE OF $225 MILLION.AMAG PHARMACEUTICALS INC - DO NOT CHANGE AMAG'S PRELIMINARY VIEW OF 2019 NEGATIVE ADJUSTED EBITDA OF APPROXIMATELY $50 MILLION.AMAG PHARMACEUTICALS - COSTS EXPECTED TO BE INCURRED IN 2019 TO ADVANCE NEW PIPELINE ASSET DO NOT CHANGE PREL VIEW OF 2019 NEGATIVE ADJUSTED EBITDA.AMAG PHARMA - IF SOME CLINICAL MILESTONES ARE MET, CIRAPARANTAG PHASE 3 PROGRAM WILL BE PARTIALLY FUNDED BY EXISTING AGREEMENT WITH GLOBAL PHARMA CO.  Full Article

AMAG Pharmaceuticals-FDA requested additional data be generated from phase 1 study with premenopausal volunteers with short term daily use of vyleesi
Tuesday, 13 Nov 2018 

Nov 13 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS-FDA REQUESTED ADDITIONAL DATA BE GENERATED FROM PHASE 1 STUDY WITH PREMENOPAUSAL VOLUNTEERS WITH SHORT TERM DAILY USE OF VYLEESI.AMAG PHARMACEUTICALS-FDA HAS INDICATED DATA ARE REQUIRED TO HELP BETTER CHARACTERIZE IMPACT OF FREQUENT DOSING, INCLUDING TO HELP INFORM VYLEESI LABEL.AMAG PHARMACEUTICALS - BELIEVES PHASE 1 STUDY CAN BE CONDUCTED & DATA SUBMITTED PRIOR TO MARCH 23, 2019, CURRENTLY SCHEDULED PDUFA DATE - SEC FILING.AMAG PHARMACEUTICALS - FDA WILL ASSESS NEED FOR ADVISORY COMMITTEE MEETING AFTER RECEIPT AND REVIEW OF REQUESTED DATA.AMAG PHARMACEUTICALS - FDA HAS INFORMED CO THAT PREVIOUSLY COMMUNICATED JANUARY 2019 ADVISORY COMMITTEE MEETING WILL NOT TAKE PLACE.AMAG PHARMACEUTICALS - BELIEVES SUBMISSION OF ADDITIONAL DATA COULD CAUSE A DELAY OF POTENTIAL APPROVAL OF VYLEESI BY 3 TO 6 MONTHS.  Full Article

AMAG Pharmaceuticals Acquires Orphan Drug Candidate For Treatment Of Severe Preeclampsia
Wednesday, 26 Sep 2018 

Sept 26 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ACQUIRES ORPHAN DRUG CANDIDATE FOR TREATMENT OF SEVERE PREECLAMPSIA.AMAG PHARMACEUTICALS INC - ACQUISITION EXPANDS AMAG'S MATERNAL HEALTH PORTFOLIO.AMAG - UPFRONT $12.5 MILLION AMAG WILL PAY IN CONNECTION WITH OPTION EXERCISE, AMAG ALSO TO BE RESPONSIBLE FOR A $35 MILLION MILESTONE PAYMENT ON FDA APPROVAL.AMAG PHARMACEUTICALS INC - WILL ALSO PAY SALES MILESTONE PAYMENTS OF AN AGGREGATE OF $240 MILLION.AMAG PHARMACEUTICALS INC - INTENDS TO INCREASE NUMBER OF TRIAL SITES, INCLUDING POTENTIALLY INITIATING SITES OUTSIDE OF U.S..AMAG PHARMACEUTICALS INC - WILL ALSO PAY MID-SINGLE DIGIT ROYALTIES BASED ON NET SALES..AMAG PHARMACEUTICALS - EXPECTED INCREMENTAL RESEARCH AND DEVELOPMENT COSTS ASSOCIATED WITH ADVANCING AMAG-423 IN 2018 DOES NOT IMPACT FINANCIAL GUIDANCE ISSUED ON AUG 2.  Full Article

AMAG Pharmaceuticals Reports Q2 Loss Per Share Of $0.75 From Continuing Operations
Thursday, 2 Aug 2018 

Aug 2 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q2 LOSS PER SHARE $0.75 FROM CONTINUING OPERATIONS.Q2 REVENUE $146.3 MILLION VERSUS I/B/E/S VIEW $155.8 MILLION.Q2 EARNINGS PER SHARE VIEW $-0.37 -- THOMSON REUTERS I/B/E/S.RAISING FULL YEAR REVENUE AND ADJUSTED EBITDA GUIDANCE FOR PHARMACEUTICAL PRODUCTS.SEES 2018 TOTAL REVENUE $525 MILLION - $565 MILLION.FY2018 REVENUE VIEW $540.3 MILLION -- THOMSON REUTERS I/B/E/S.  Full Article

AMAG Pharma Says To Launch Authorized Generic Version Of Single-Dose Intramuscular Formulation Of Makena Into U.S
Monday, 25 Jun 2018 

June 25 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMA - TO LAUNCH AUTHORIZED GENERIC VERSION OF SINGLE-DOSE INTRAMUSCULAR FORMULATION OF MAKENA INTO THE U.S. MARKET THROUGH PRASCO LABORATORIES.  Full Article

AMAG Pharmaceuticals Receives FDA Acceptance Of New Drug Application Filing For Bremelanotide
Monday, 4 Jun 2018 

June 4 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FILING FOR BREMELANOTIDE.AMAG PHARMACEUTICALS - PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE FOR COMPLETION OF FDA REVIEW OF BREMELANOTIDE NDA IS MARCH 23, 2019.  Full Article

AMAG Pharmaceuticals Submits NDA To FDA For Bremelanotide
Monday, 26 Mar 2018 

March 26 (Reuters) - Amag Pharmaceuticals Inc ::AMAG PHARMACEUTICALS SUBMITS A NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR BREMELANOTIDE FOR THE TREATMENT OF HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) IN PREMENOPAUSAL WOMEN.  Full Article