September 27, 2013 (Update) - On September 25, 2013, AMAG Pharmaceuticals, Inc. disclosed that on September 23, 2013, the Company received a notification from the U.S. Food and Drug Administration (the FDA) stating that, as part of its ongoing review of the Companys supplemental New Drug Application for its Feraheme Injection, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments by September 23, 2013, a target date previously communicated by the FDA in a letter dated March 5, 2013.
Shares of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) declined from $26.87 per share on Sept. 24, 2013, to $21.65 per share on Sept. 27, 2013.
May 28, 2013 (Shareholders Foundation) - An investigation on behalf of investors of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) shares over potential securities laws violations by AMAG Pharmaceuticals and certain of its directors and officers in connection certain financial statements was announced .
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) concerning whether a series of statements by AMAG Pharmaceuticals regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
AMAG Pharmaceuticals, Inc. reported that its annual Total Revenue increased from $17.18 million in 2009 to $85.38 million in 2012 and that its respective Net Loss declined from $93.35 million to $16.75 million.
NASDAQ:AMAG shares grew from slightly over $15 per share in Jan. 2013 to as high as $23.85 per share in late March 2013.
Then on May 21, 2013, AMAG Pharmaceuticals, Inc. announced that it has been made aware by Takeda Pharma AG, the exclusive product distributor of ferumoxytol in Switzerland, that it is recalling one specific batch of Rienso (ferumoxytol) from the Swiss market.
Shares of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) declined from $25.14 per share on May 21, 2013 to as low as $21.76 per share on May 24, 2013.
On May 28, 2013, NASDAQ:AMAG shares closed at $22.24 per share.