SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of AMAG Pharmaceuticals, Inc. – AMAG
NEW YORK, NY / CRWEPRESSRELEASE / July 27, 2015 / Pomerantz LLP is investigating claims on behalf of investors of AMAG Pharmaceuticals, Inc. (“AMAG” or the “Company”). Such investors are advised to contact Robert S. Willoughby at email@example.com or 888-476-6529, ext. 9980.
The investigation concerns whether AMAG and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
On January 22, 2014, the Company announced that the FDA has issued a complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease 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.
On this news, shares of AMAG fell $1.68 per share to more than 7.69% on intraday trading to a price of $20.18 on January 22, 2014.
On January 9, 2015 the Company announced that, “on June 2, 2014, AMAG Pharmaceuticals, Inc. (the “Company”) proposed to the U.S. Food and Drug Administration (“FDA”) changes to the current U.S. label of Feraheme (ferumoxytol) Injection based on a review of global post-marketing data. The intended purpose of the label changes in the U.S. was to strengthen the warnings and precautions section of the label and mitigate the risk of serious hypersensitivity reactions, including anaphylaxis, in order to enhance patient safety. The proposed changes were subject to review and approval by the FDA.
After considering the Company’s June 2014 submission and other information, on January 7, 2015, the FDA notified the Company that it believes new safety information should be included in the labeling for Feraheme, including, among other things, a boxed warning to highlight the risks of serious hypersensitivity/anaphylaxis reactions and revisions that Feraheme should only be administered through an intravenous (“IV”) infusion (i.e., not by IV injection) and should be contraindicated for patients with any known history of drug allergy. The FDA’s recommended label changes go beyond what the Company proposed in June 2014.”
On this news, shares of AMAG fell $3.13 per share to more than 6.81%, on intraday trading to a price of $42.85 on January 9, 2015.
On May 28, 2015, the Company announced that “it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its manufacturing supplement seeking approval for a single-dose vial of Makena. A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA requested additional information related to manufacturing procedures for the single-dose vial at a new third-party manufacturer.”
On July 27, 2015 AMAG filed a quarterly report on 10-Q with the SEC, stating in part that the Federal Trade Commission (FTC) had notified the company on July 20, 2015 that the FTC is conducting an investigation with respect to Makena, the company’s preterm birth prevention drug, or any hydroxyprogesterone caproate product.
On this adverse news, AMAG shares have fallen as much as 4.42, or 6.27%, on intraday trading on July 27, 2015.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Florida, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 70 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.