SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of
Investors of AMAG Pharmaceuticals, Inc. - AMAG
NEW YORK, Jan. 22, 2014
NEW YORK, Jan. 22, 2014 /PRNewswire/ -- Pomerantz LLP is investigating claims
on behalf of investors of AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG)("AMAG" or
the "Company"). Such investors are advised to contact Robert S. Willoughby at
email@example.com or 888-476-6529, ext. 237.
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 December 21, 2012, AMAG submitted to the U.S. Food and Drug Administration
(the "FDA") a supplemental New Drug Application (the "sNDA") under section
505(b) of the Federal Food, Drug, and Cosmetic Act for Feraheme (ferumoxytol)
Injection, 510 mg. The sNDA sought approval for a broader indication for
Feraheme for the treatment of iron deficiency anemia in adult patients who
have failed or could not use oral iron. On September 23, 2013, the Company
received a notification from the FDA stating that, as part of its ongoing
review of the Company's sNDA, 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. On September 25, 2013 the Company announced in an
Securities and Exchange Commission Form 8-K filing, information regarding the
FDA notification received on September 23, 2013.
On January 7, 2014, the Company had a discussion with the FDA regarding the
status of the review of the sNDA. The FDA indicated that the sNDA is under
active review; however, the FDA has not yet entered into discussions with the
Company regarding proposed labeling or postmarketing requirement/commitment
requests for the broader indication for Feraheme.
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.
The Pomerantz Firm, with offices in New York, Chicago, San Diego 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.
Robert S. Willoughby
SOURCE Pomerantz LLP
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