Edition:
United Kingdom

AMAG Pharmaceuticals Inc (AMAG.OQ)

AMAG.OQ on NASDAQ Stock Exchange Global Select Market

18.21USD
19 Nov 2018
Change (% chg)

-- (--)
Prev Close
$18.21
Open
--
Day's High
--
Day's Low
--
Volume
--
Avg. Vol
206,184
52-wk High
$26.08
52-wk Low
$11.95

Latest Key Developments (Source: Significant Developments)

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

Orchard Therapeutics appoints Frank Thomas as CFO
Wednesday, 17 Jan 2018 

Jan 17 (Reuters) - Orchard Therapeutics: :ORCHARD THERAPEUTICS APPOINTS FRANK THOMAS AS CHIEF FINANCIAL OFFICER AND CHIEF BUSINESS OFFICER​.ORCHARD THERAPEUTICS SAYS ‍UNTIL RECENTLY THOMAS SERVED AS PRESIDENT AND CHIEF OPERATING OFFICER OF AMAG PHARMACEUTICALS​.  Full Article

AMAG Pharmaceuticals Sees Q4 2017 Revenue $156 Mln to $163 Mln
Monday, 8 Jan 2018 

Jan 8 (Reuters) - AMAG Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ANNOUNCES PRELIMINARY 2017 FINANCIAL RESULTS AND PROVIDES 2018 GUIDANCE.SEES Q4 2017 REVENUE $156 MILLION TO $163 MILLION.SEES FY 2017 REVENUE $613 MILLION TO $620 MILLION.SEES FY 2017 REVENUE UP 15 PERCENT.SEES Q4 2017 REVENUE UP ABOUT 5 PERCENT.- ‍FOR Q4 OF 2017, AMAG EXPECTS AN OPERATING LOSS OF BETWEEN $6 MILLION AND $16 MILLION​.- ‍EXPECTS 2017 TOTAL GAAP REVENUE TO BE BETWEEN $607 MILLION AND $614 MILLION​.SEES ‍ 2017 OPERATING LOSS OF BETWEEN $292 MILLION AND $302 MILLION (DUE PRIMARILY TO A Q3 NON-CASH ACCOUNTING CHARGE)​.SEES ‍2018 TOTAL GAAP REVENUE $500 MILLION - $560 MILLION​.SEES ‍2018 GAAP OPERATING LOSS $147 MILLION - $117 MILLION​.Q4 REVENUE VIEW $161.1 MILLION -- THOMSON REUTERS I/B/E/S.FY2017 REVENUE VIEW $616.0 MILLION -- THOMSON REUTERS I/B/E/S.FY2018 REVENUE VIEW $504.1 MILLION -- THOMSON REUTERS I/B/E/S.  Full Article

Palatin Technologies signs licensing agreement with Kwangdong Pharma
Tuesday, 21 Nov 2017 

Nov 21 (Reuters) - Palatin Technologies :Palatin Technologies announces signing of licensing agreement with Kwangdong Pharmaceutical for Republic of Korea.A NDA anticipated to be filed with U.S. Food and Drug Administration in Q1 of calendar year 2018​.  Full Article

Amag Pharmaceuticals Q3 loss per share $4.31
Thursday, 2 Nov 2017 

Nov 2 (Reuters) - Amag Pharmaceuticals Inc :Amag Pharmaceuticals announces third quarter 2017 financial results and business highlights.Q3 loss per share $4.31.Q3 earnings per share view $0.18 -- Thomson Reuters I/B/E/S.Q3 revenue $153.7 million versus I/B/E/S view $168.5 million.Amag Pharmaceuticals Inc - ‍co has updated 2017 Makena revenue guidance to between $385 million and $395 million​.  Full Article