Key Developments: AMAG Pharmaceuticals Inc (AMAG.OQ)
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1 Aug 2013
$1.11 (+4.93%)
$22.50
$23.15
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Latest Key Developments (Source: Significant Developments)
AMAG Pharmaceuticals Inc Raises FY 2013 Revenue Guidance
AMAG Pharmaceuticals Inc updated its annual financial guidance for fiscal 2013. AMAG now expects to achieve the following in fiscal 2013: Total revenues of between $77 million and $80 million, including: Feraheme U.S. net product sales of between $67 million and $70 million, revised upward from the Company's previous estimate of between $63 million and $67 million; Revenues from other sources of approximately $10 million, including ex-U.S. Feraheme/Rienso product sales, royalties and amortization of milestones as well as MuGard product sales. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $76 million for fiscal 2013. Full Article
Access Pharmaceuticals Inc Signs US License Agreement With AMAG Pharmaceuticals Inc For MuGard
Access Pharmaceuticals Inc announced that it had entered into an exclusive license agreement with AMAG Pharmaceuticals, Inc related to the commercialization of MuGard in the US and its territories. Under the terms of the license agreement, Access will receive an upfront licensing fee of $3.3 million and a tiered, double digit royalty on net sales of MuGard in the licensed territories. AMAG will also purchase existing MuGard inventory from Access. MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients developing the condition each year. Full Article
Pomerantz Law Firm Reminds Shareholders with Losses on Their Investment in AMAG Pharmaceuticals Inc of Class Action Lawsuit Investigation
Pomerantz Grossman Hufford Dahlstrom & Gross LLP announced that it is investigating claims on behalf of investors of AMAG Pharmaceuticals Inc who purchased AMAG common stock between May 10, 2012 and May 21, 2013 (the Class Period). On May 22, 2013, the Company announced in regulatory filing that it has been made aware by Takeda Pharmaceutical Company Limited, the exclusive product distributor of ferumoxytol in Switzerland, that it is recalling one specific batch of Rienso, ferumoxytol, from the Swiss market. This decision is based on a cluster of four post-marketing adverse event reports in Switzerland concerning hypersensitivity reactions of varying severity following the administration of Rienso from the recalled batch, and at least one fatality has occurred as a result of the use of the drug in Switzerland. On this news announcement, shares of AMAG fell $2.68 or 10.68% to close at $22.40 on May 22, 2013. Full Article
Bronstein, Gewirtz & Grossman, LLC Announces Investigation Of AMAG Pharmaceuticals Inc
Bronstein, Gewirtz & Grossman, LLC announced that it is investigating potential claims on behalf of purchasers of the securities of AMAG Pharmaceuticals, Inc. (AMAG or the Company). The investigation focuses on whether the Company and its executives violated federal securities laws. On May 22, 2013, Shares of AMAG dropped $2.69 or 10.73% during intraday trading after the Company announced in regulatory filing that it has been made aware by Takeda Pharmaceutical Company Limited, the exclusive product distributor of ferumoxytol in Switzerland, that it is recalling one specific batch of Rienso, ferumoxytol, from the Swiss market. This decision is based on a cluster of four post-marketing adverse event reports in Switzerland concerning hypersensitivity reactions of varying severity following the administration of Rienso from this batch. One of these cases included a report of a fatality. Full Article
AMAG Pharmaceuticals Inc Announces Ferumoxytol Treatment Produced Hemoglobin Increases In Adult Iron Deficiency Anemia Patients With Gastrointestinal Disease
AMAG Pharmaceuticals Inc announced that a new sub-group analysis from IDA-301, a phase III, randomized, placebo-controlled clinical trial, will be presented today at a poster session of the Digestive Disease Week 2013 (DDW) meeting in Orlando, Florida. In the full IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo. The sub-group analysis being presented today at DDW is based on 231 patients in IDA-301 with gastrointestinal (GI) disease. Of these patients, 173 were randomized to the ferumoxytol treatment arm and 58 to the placebo arm. IDA-301 was a multicenter trial designed to compare the safety and efficacy of a one gram course of ferumoxytol versus placebo in adult patients with IDA who had failed or could not tolerate oral iron treatment, regardless of the underlying cause. Ferumoxytol is an IV iron treatment currently approved in the United States for the treatment of IDA in adult chronic kidney disease patients. IDA-301 was one of two studies that formed the foundation for AMAG's supplemental new drug application (sNDA) in the United States, which was filed in December 2012. AMAG's sNDA seeks to expand the use of Feraheme (ferumoxytol) for adult IDA patients who have failed or could not tolerate oral iron, including those patients with GI disease. Full Article
AMAG Pharmaceuticals Inc Reaffirms FY 2013 Revenue Guidance
AMAG Pharmaceuticals Inc reiterated guidance for fiscal 2013 and expects total revenues of between $73 million and $77 million, including Feraheme U.S. net product sales of between $63 million and $67 million; revenue from royalties, ex-U.S. product sales and milestones of approximately $10 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $76 million for fiscal 2013. Full Article
AMAG Pharmaceuticals Inc Announces Positive Preliminary Results From Extension Study Evaluating Safety And Efficacy Of Repeat Dosing With Ferumoxytol
AMAG Pharmaceuticals Inc announced positive preliminary data from the IDA-303 study. IDA-303 is a single arm, open-label extension study that evaluated safety and efficacy of repeat dosing with ferumoxytol in patients with persistent or recurring iron deficiency anemia (IDA) regardless of the underlying cause and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Total of 634 patients were enrolled and qualified for ongoing observation/treatment in IDA-303. Of the 634 patients enrolled in IDA-303, 471 had previously received one treatment course with ferumoxytol in the IDA-301 study, and the remainder had received placebo. Patients were eligible for ferumoxytol treatment in IDA-303 if their hemoglobin levels fell below 11 g/dL and their transferrin saturation (TSAT) levels were less than 20%. During the course of the IDA-303 study, 337 patients were treated with ferumoxytol; 151 of these patients had received placebo in IDA-301 and therefore received their first course of ferumoxytol in the IDA-303 study. A total of 244 patients received a second course of ferumoxytol, of whom 186 patients had received their first course in IDA-301. The primary efficacy endpoint of the extension study was the mean change in hemoglobin from baseline to week five following the first course of ferumoxytol. The 151 patients who received their first course of therapy in IDA-303 achieved a statistically mean in hemoglobin from baseline to week five of 2.6 g/dL. Full Article
AMAG Pharmaceuticals Inc Announces FDA Acceptance Of Supplemental New Drug Application For Feraheme Label Expansion
AMAG Pharmaceuticals Inc announced that the United States Food and Drug Administration (FDA) has accepted for review the Company's supplemental new drug application (sNDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to adult patients with IDA who have failed or could not take oral iron treatment. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the sNDA is subject to a 10-month review by the FDA. With the acceptance of the submission, the FDA has set October 21, 2013 as a target date for completion of their review. Full Article
AMAG Pharmaceuticals Inc Reaffirms FY 2013 Guidance
AMAG Pharmaceuticals Inc reaffirmed fiscal 2013 guidance and expects total revenues of between $73-$77 million, including: Feraheme U.S. net product sales of between $63-$67 million; revenue from royalties, ex-U.S. product sales and milestones of approximately $10 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $77 million for fiscal 2013. Full Article
Branham Law, LLP Investigates AMAG Pharmaceuticals Inc On Behalf Of Stockholders
Branham Law, LLP announced that it is investigating AMAG Pharmaceuticals Inc and certain of its officers and directors for potential breaches of fiduciary duties in connection with AMAG`s apparent failure to disclose that users of the Company's primary drug, Feraheme had suffered adverse reactions, including hospitalizations and one possible death. On February 4, 2013, the United States First Circuit Court of Appeals reversed the district court`s dismissal of these claims and reinstated the action. After these failures to disclose were revealed, AMAG`s stock fell over $7.00 per share. Subsequent disclosures regarding the Company's rebate program resulted in a further drop of $4.02 per share. Full Article
CORRECTED-Amag investigates anemia drug after report of death in Switzerland
(Corrects headline to "investigates." Amag did not say the drug caused the fatality.)

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