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AMAG Pharmaceuticals Inc

AMAG Pharmaceuticals Inc (AMAG)

13.75
0.00
(0.00%)
Closed December 22 3:00PM
0.00
0.00
(0.00%)

Professional-Grade Tools, for Individual Investors.

AMAG News

Official News Only

AMAG Discussion

View Posts
T695 T695 4 years ago
Back to the $9’s in the morning lol
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beachlover beachlover 4 years ago
Rumors of buyout with Clovis
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Abdullah10 Abdullah10 4 years ago
Nothing been posted here for a while but I love what I’m seeing. Bug gains will be made here long term????
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xgin xgin 5 years ago
Insider Transactions
Do insider trades predict future price movements?

Even though it is illegal for company insiders to trade on material non-public information, there is a body of academic research that suggests insiders outperform the general public when trading shares of their own companies. This is known as the insider trading anomaly, and it is one of the few trading anomalies that exist in the modern capital markets. By analyzing the historical trading patterns of insiders, we provide the tools and analysis that allow investors to exploit the insider trading anomaly for their own benefit.
Fintel provides analysis to identify trades that predict future price moments.

We do this by analyzing the price movements of stocks subsequent to insider trades and doing statistical analysis to determine if the trades correlate to winning trades.

Click on the name of the insider in the table below to see the statistical analysis and trading performance for the insider.
Tran
Date Stock Form Insider Code 10b5-1
Plan Direct Share
Price Shares
Changed Remaining
Shares Post Value
AMAG 3 Kelly Schick D 34,300
AMAG 3 Kelly Schick D 34,300
AMAG 3 Kelly Schick D 34,300
2020-01-27 AMAG 4 Steven Boyd P - Purchase D 9.43 8,000 4,120,000 38,851,600
2020-01-27 AMAG 4 Steven Boyd P - Purchase I 9.41 8,000 288,000 2,710,080
2020-01-27 AMAG 4 Steven Boyd P - Purchase I 0 4,120,000
2020-01-24 AMAG 4 Steven Boyd P - Purchase D 9.58 34,000 4,112,000 39,392,960
2020-01-24 AMAG 4 Steven Boyd P - Purchase I 9.72 40,000 280,000 2,721,600
2020-01-24 AMAG 4 Steven Boyd P - Purchase I 0 4,112,000
2020-01-10 AMAG 4 Steven Boyd P - Purchase I 0 4,318,000
2020-01-10 AMAG 4 Steven Boyd P - Purchase D 11.64 18,000 4,318,000 50,261,520
2020-01-09 AMAG 4 Steven Boyd P - Purchase D 12.33 12,466 4,300,000 53,019,000
2020-01-09 AMAG 4 Steven Boyd P - Purchase I 0 4,300,000
2020-01-09 AMAG 4 Steven Boyd S - Sale I 0 4,287,534
2020-01-09 AMAG 4 Steven Boyd S - Sale D 12.43 -12,466 4,287,534 53,294,048
2019-12-16 NK 4 John C Thomas S - Sale X D 3.14 -10,000 343,955 1,080,019
2019-12-13 NK 4 John C Thomas S - Sale X D 2.48 -10,000 363,955 902,608
2019-12-13 NK 4 John C Thomas S - Sale X D 2.98 -10,000 353,955 1,054,786
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ClayTrader ClayTrader 5 years ago
* * $AMAG Video Chart 01-24-2020 * *

Link to Video - click here to watch the technical chart video

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xgin xgin 5 years ago
I hate guys who post off topic so I need to hate myself, but check out this interview. It spiked yesterday and lost half it's gains today.
Has anyone considered what would happen if the CEO's interview hits CNN & Fox?
https://www.bloomberg.com/news/articles/2020-01-13/nantkwest-gains-after-ceo-says-cancer-drug-produced-early-result
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johnb214 johnb214 5 years ago
NEW TARGET RANGES WITH A STRONG BUY WITH PTN TO FOLLOW:
SIX Months: 15.04 One year: 17.57
Support: Support1: 11.48 Support2: 10.62
Resistance: Resistance1: 12.88 Resistance2: 15.04
Pivot: 11.47
Moving Average: MA(5): 11.85 MA(20): 11.47
MA(100): 10.50 MA(250): 12.90
MACD: MACD(12,26): 0.09 Signal(9): -0.01
Stochastic oscillator: %K(14,3): 60.35 %D(3): 55.78
RSI: RSI(14): 59.19
52-week: High: 22.30 Low: 6.81 Change(%): -41.0
Average Vol(K): 3-Month: 112668 10-Days: 59199
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johnb214 johnb214 5 years ago
PTN/AMAG
AMAG This is the first part of a possible takeover. They have at least 10% of the stock and have filed a 13c with the SEC. They have to hold the stock for at least six months and the question is, do they have to report when they buy more or does it become a mystery. They know that the drug is going to be a blockbuster and this could be a backdoor for taking over PTN.
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Monroe1 Monroe1 5 years ago
The short attack has started by those wanting to take over.
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Monroe1 Monroe1 5 years ago
I concur. Good post.
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johnb214 johnb214 5 years ago
II I like AMAG and they made a great investment in the PTN drug. Here is my view. Here is my perspective on the locked price plus or minus a few cents. It is rather obvious that someone is trying to manipulate the price with fake trades on low volume in conjunction with the takeover interest in AMAG. They want the drug and the mega potential profits. They don't like the management in either company and they have the money to take over both companies. It is all about the price they must pay. Are they playing dirty? I suspect so. That will eventually will be known. It will be good for us and maybe a white knight will arrive with more money. I see a great future in the Peptide drugs in the pipeline. Besides the money, look what they are doing for future drug applications.
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johnb214 johnb214 5 years ago
II WHICH IS THE BETTER BUY? FROM ANOTHER POST: amag vs ptn
12.16÷.88 = 13.82
AMAG is 13 times more expensive
than PTN
For the same investment $
you can buy 13 times more PTN shares

However AMAG has 34 mill shares out
vs PTN has 190 mill shares
190÷34 = 5.58
or PTN has 6 times as many shares

So bang fer buck
13÷6=2
PTN is 2 times a better investment

And PTN has the pipeline
AMAG has the injector
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ClayTrader ClayTrader 5 years ago
* * $AMAG Video Chart 08-12-2019 * *

Link to Video - click here to watch the technical chart video

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runcaly runcaly 5 years ago
And thats the reason for the 25% decline ...

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) major shareholder Camber Capital Management Lp bought 385,000 shares of the stock in a transaction on Friday, August 9th. The stock was purchased at an average price of $7.87 per share, for a total transaction of $3,029,950.00. The purchase was disclosed in a document filed with the SEC, which can be accessed through this link. Major shareholders that own at least 10% of a company’s shares are required to disclose their sales and purchases with the SEC.
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johnb214 johnb214 5 years ago
$AMAG/PTN 15 TRADING DAYS UNTIL LAUNCH OF THE DRUG TO THE PUBLIC. WE HAVE NOT HEARD ABOUT THE OTHER DISTRIBUTORS AND THE FUTURE ONES. I STILL THINK A COMPANY CAN ACQUIRE AMAG AND THEN PTN OR VICE VERSA. KING PHARMA HAD A LARGE POSITION IN PTN YEARS AGO AND THEY GOT BOUGHT OUT BY PHYSER AND THEN PHYSER WAS WORKING ON OTHER DRUGS WITH PTN. IT WOULD BE A GOOD MATCH. PTN DID ANNOUNCE ABOUT THIRTY DAYS AGO THAT THEY WERE MEETING WITH OTHER POTENTIAL PARTNERS. I THINK SOMETHING WILL HAPPEN PRIOR TO LAUNCH DATE. AMAG IS ALREADY GATHERING STEAM AND IS LEAVING THE STATION WITH THE NEWS MEDIA FOLLOWING. I SEE ANOTHER 10% INCREASE MONDAY. THEN WE HAVE A BREAKOUT.
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ClayTrader ClayTrader 5 years ago
* * $AMAG Video Chart 08-09-2019 * *

Link to Video - click here to watch the technical chart video

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johnb214 johnb214 5 years ago
AMAG/PTN 16 TRADING DAYS UNTIL LAUNCH OF THE DRUG TO THE PUBLIC. WE HAVE NOT HEARD ABOUT THE OTHER DISTRIBUTORS AND THE FUTURE ONES. I STILL THINK A COMPANY CAN ACQUIRE AMAG AND THEN PTN OR VICE VERSA. KING PHARMA HAD A LARGE POSITION IN PTN YEARS AGO AND THEY GOT BOUGHT OUT BY PHYSER AND THEN PHYSER WAS WORKING ON OTHER DRUGS WITH PTN. IT WOULD BE A GOOD MATCH. PTN DID ANNOUNCE ABOUT THIRTY DAYS AGO THAT THEY WERE MEETING WITH OTHER POTENTIAL PARTNERS. I THINK SOMETHING WILL HAPPEN PRIOR TO LAUNCH DATE.
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runcaly runcaly 5 years ago
Thats is the beautiful great us-Market.
After CC there put it down 25 % and then today ..
All is good.
I like this so called market...
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runcaly runcaly 5 years ago
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runcaly runcaly 5 years ago
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Monroe1 Monroe1 5 years ago
Today Reuters News on AMAG to sell Vyleesi for $899 is intentionally conglomerated and misleading with ADDYI by BNC corp.

I've noticed a lot of PR's in the pharmaceutical world as quite prejudiced toward the existing Big Pharma when competition is on the horizon of being introduced. As well the analysts really bend toward the existing brands.


Amag's female libido injectable therapy to sell at $899
BY Reuters
— 12:21 PM ET 08/06/2019

By Saumya Joseph

Aug 6 (Reuters) - Amag Pharmaceuticals Inc's ( AMAG

) treatment to boost sexual desire in premenopausal women will be offered at $899 and is the only injectable drug on the market for the condition.

The therapy, Vyleesi, was approved in June and will be available in September through the company's specialty pharmacy distribution network that would deliver the treatment to patients' homes.
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johnb214 johnb214 5 years ago
Cramer on Mad Money on his lightning round commented on AMAG last night and that could be the reason it is up 10.3% this morning on a half million shares. Next Wednesday is news and earnings day at 8AM before the markets open.
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xgin xgin 5 years ago
https://seekingalpha.com/article/4272821-daily-insider-ratings-round-6-27-19
On Today's Tables: Insider trades were rated Significant at:
Tejon Ranch (TRC);
Nicholas Financial (NICK);
AMAG Pharm (AMAG);
Agree Realty (ADC).

To the tune of 7 million dollars worth of stock.
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#NeverPennyLand #NeverPennyLand 5 years ago
Thanks I bailed at 938.
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MD3 MD3 5 years ago
Good call
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#NeverPennyLand #NeverPennyLand 5 years ago
I think it bounces back to 9.50 ish tomorrow. I bought 1000 shares at 8.41 today. We shall see.
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MD3 MD3 5 years ago
New 52 week low locked in the books. How low can she go
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MD3 MD3 5 years ago
Looks that way
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#NeverPennyLand #NeverPennyLand 5 years ago
Yes and terrible, getting shorted even more. Wants to see a new low I guess
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MD3 MD3 5 years ago
Is this a sell the news scenario?
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MD3 MD3 5 years ago
Hmmmmm.... are we going to close the gap this morning or just run. Looking for an entry. The volume here is very low so it shouldn't be difficult for the shorts to force the PS down
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VivaLasVegas VivaLasVegas 6 years ago
Shorts that will be covering for months
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MD3 MD3 6 years ago
FDA approved
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jonny_red jonny_red 6 years ago
$PTN $AMAG - Sex Drug’s FDA Approval Could Spur Turnaround for Amag Pharma Shares

https://www.transparenttraders.me/2019/06/ptn-amag-sex-drugs-fda-approval-could.html



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tmeier tmeier 6 years ago
They paying 60 mill to PTN on the 23rd!!Yea baby!!
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BesaoT35 BesaoT35 6 years ago
From 25 to 10. What was the reason for such a large decline?
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Monroe1 Monroe1 6 years ago
Another lawsuit coming??? Similar to AVEO.
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Monroe1 Monroe1 6 years ago
Makena fails to make end point. At $11 and 15% down and going to $6???
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-Crystal- -Crystal- 6 years ago
.
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FredKerx FredKerx 7 years ago
KERX True Longs...

epgonline.org is for healthcare professionals. It is funded through grants/sponsorship from pharma companies and other organisations supporting the provision of high quality, up-to-date, medical information. It is published by EPG Health Media (Europe) Ltd..

Following is eponline info. for FEXERIC with data from European Medicines Agency (EMC) added since July 2016 and updated September 2017..

(Full prescibing information for FEXERIC directed/marketed to healthcare professionals in Europe available since July 2016 and updated September 2017?)..
 
U.K.
https://www.epgonline.org/uk/drugs/fexeric/

Italy
https://www.epgonline.org/it/drugs/fexeric/

France
https://www.epgonline.org/fr/drugs/fexeric/

Spain
https://www.epgonline.org/es/drugs/fexeric/

Germany
https://www.epgonline.org/de/drugs/fexeric/

Netherland
https://www.epgonline.org/nl/drugs/fexeric/

Portugal
https://www.epgonline.org/pt/drugs/fexeric/

Sweden
https://www.epgonline.org/se/drugs/fexeric/
___________________________________

Now, check this out.

SUKL is State Agency for Drug Control in Czech Republic. FEXERIC tablets - 1G Tablets, 200 count package?

http://www.sukl.eu/modules/medication/detail.php?kod=0186944

Slovakia

https://mediately.co/hr/drugs/GQK3wZIIi3HSswEEilNBGBbdxZ9/fexeric-1-g-filmom-oblozene-tablete

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bige777 bige777 7 years ago
Up 25% today on FDA approval of their auto injector!!
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Garycool89 Garycool89 7 years ago
Been thinking about getting on this stock for a while so i created an ihub account to get it on the conversation :)
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Deehrm29 Deehrm29 9 years ago
Nice little run here.
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Bx3 Bx3 9 years ago
Just wanted to note,; average trade vol recently is 1.7 shares /day. On yerserdays down turn there was days exchange listed at over 4.5 mill shares traded, but actually the downturn was for only about 1.79 mill shares exchd thru entire day. In Last few min the downturn reversed on hi vol, taking accumulation to astronomically hi level. In last few min exchange was approx 3.2 mill shares going up, exchd including last one minute of day which was at the higher end of the upward reversal, at about 2.5 mill shares. The extreme gross maj of shares traded were at very end of day on upsweep, but it would appear to most that 4.5mill was on total day of 2.5% downturn. Not so. Correct me if I am in error, please, aLL STATED IS imo.
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vectorinformatics vectorinformatics 9 years ago
Steinmeyer Law launches class action lawsuit against AMAG Steinmeyer Law AMAG Class Action Homepage
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magness magness 9 years ago
Growth biotech trading at less than 3x cash and highly profitable.
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GreenpandaXO GreenpandaXO 10 years ago
10k short in EOD
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stocktrademan stocktrademan 10 years ago
$AMAG DD Notes ~ http://www.ddnotesmaker.com/AMAG

bullish

$AMAG recent news/filings

## source: finance.yahoo.com

Fri, 28 Nov 2014 21:00:02 GMT ~ Alexion's Soliris Gets Final Positive NICE Recommendation


read full: http://finance.yahoo.com/news/alexions-soliris-gets-final-positive-210002335.html
*********************************************************

Fri, 28 Nov 2014 20:30:02 GMT ~ Mylan (MYL) Sued By Baxter for Generic Filing of Brevibloc


read full: http://finance.yahoo.com/news/mylan-myl-sued-baxter-generic-203002361.html
*********************************************************

Fri, 28 Nov 2014 20:20:02 GMT ~ Merge Healthcare, Primordial to Improve Radiology Solutions


read full: http://finance.yahoo.com/news/merge-healthcare-primordial-improve-radiology-202002871.html
*********************************************************

Fri, 28 Nov 2014 15:49:40 GMT ~ Glaxo's Ebola Candidate Well-Tolerated in Early U.S. Study


read full: http://finance.yahoo.com/news/glaxos-ebola-candidate-well-tolerated-154940662.html
*********************************************************

Fri, 28 Nov 2014 11:41:13 GMT ~ uniQure N.V. (QURE) in Focus: Stock Soars 17.6%


read full: http://finance.yahoo.com/news/uniqure-n-v-qure-focus-114113150.html
*********************************************************


$AMAG charts

basic chart ## source: stockcharts.com



basic chart ## source: stockscores.com



big daily chart ## source: stockcharts.com



big weekly chart ## source: stockcharts.com


$AMAG company information

## source: otcmarkets.com

Link: http://www.otcmarkets.com/stock/AMAG/company-info
Ticker: $AMAG
OTC Market Place: Not Available
CIK code: 0000792977
Company name: AMAG Pharmaceuticals, Inc.
Company website: http://www.amagpharma.com
Incorporated In: DE, USA


$AMAG share structure

## source: otcmarkets.com

Market Value: $821,925,407 a/o Nov 28, 2014
Shares Outstanding: 22,094,769 a/o Oct 31, 2014
Float: Not Available
Authorized Shares: Not Available
Par Value: 0.01
$AMAG extra dd links

Company name: AMAG Pharmaceuticals, Inc.
Company website: http://www.amagpharma.com

## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=AMAG+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=AMAG+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=AMAG+Industry

## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/AMAG/news - http://finance.yahoo.com/q/h?s=AMAG+Headlines

## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/AMAG/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/AMAG/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=AMAG+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/AMAG
DTCC (dtcc.com): http://search2.dtcc.com/?q=AMAG+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=AMAG+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=AMAG+Pharmaceuticals%2C+Inc.&x=0&y=0
WHOIS (domaintools.com): http://whois.domaintools.com/http://www.amagpharma.com
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.amagpharma.com#
Corporate website internet archive (archive.org): http://web.archive.org/web/*/http://www.amagpharma.com

## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/AMAG
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000792977&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/AMAG/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/AMAG/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=AMAG&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=AMAG
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/AMAG/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=AMAG+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=AMAG+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=AMAG
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=AMAG
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=AMAG+Cash+Flow&annual

## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/AMAG/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=AMAG+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/AMAG.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=AMAG
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/AMAG/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/AMAG/insider-transactions

## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/AMAG
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/AMAG
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/AMAG:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=AMAG
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=AMAG



$AMAG DD Notes ~ http://www.ddnotesmaker.com/AMAG
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TheFinalCD TheFinalCD 11 years ago
The conversion rate for the notes will initially be 36.9079 shares of AMAG's common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $27.09 per share, and is subject to adjustment under the terms of the notes. This represents a premium of approximately 35% over the last reported sale price of $20.07 per share of AMAG's common stock on The NASDAQ Global Select Market on February 11, 2014
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surf1944 surf1944 11 years ago
7:43AM AMAG Pharma is lower by 13% at 19.00 following news of complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use (AMAG) 21.86 :

See 6:57 comment for details.
As mentioned, the FDA has issued a complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use.
The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death.
6:57AM AMAG Pharma announced the FDA has issued a complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use; FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death (AMAG) 21.86 :

Co announced that the FDA has issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous (IV) use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment.
In the letter, the FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA indicated that its decision was based on the cumulative ferumoxytol data, including the global phase III IDA program and global post-marketing safety reports. The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death. Additionally, the FDA proposed potentially evaluating alternative dosing and/or administration of Feraheme. AMAG is assessing the content and recommendations of the letter and plans further discussions with the FDA.
"In the coming weeks, we intend to work with the FDA to determine the best regulatory path for Feraheme in this broader IDA patient population."
Co will host a conference call and webcast today at 7:30 a.m. ET, during which management will discuss the complete response letter.
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