Key Developments: AMAG Pharmaceuticals Inc (AMAG.O)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
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
AMAG Pharmaceuticals Inc Issues Q4 2012 And FY 2013 Revenue Guidance Below Analysts' Estimates
AMAG Pharmaceuticals Inc announced that for the fourth quarter of 2012, it expects total revenues of between $21.1 million and $21.5 million, including between $14.4 million and $14.8 million of net U.S. Feraheme product revenues. The Company also announced that it expects to achieve total revenues of between $73 million and $77 million for fiscal 2013, including: Feraheme U.S. net product revenues of between $63 million and $67 million, driven by a combination of price and double-digit volume growth; and Royalties and product sales related to ex-U.S. sales of Feraheme/Rienso and recognition of milestones of approximately $10 million. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $29.9 million for the fourth quarter of 2012 and revenue of $79 million for fiscal 2013. Full Article
AMAG Pharmaceuticals Inc Announces FDA Submission of Supplemental New Drug Application for Feraheme
AMAG Pharmaceuticals Inc announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use. 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 all adult patients with IDA who have failed or could not tolerate oral iron treatment. The application includes data from two well-controlled phase III clinical trials of more than 1,400 patients. Full Article
AMAG Pharmaceuticals Inc Announces Positive Preliminary Results From Phase III Study Evaluating Feraheme Compared To Placebo In Patients With Iron Deficiency Anemia
AMAG Pharmaceuticals Inc announced preliminary results from the second phase III study from its global registrational program for Feraheme® (ferumoxytol) in patients with iron deficiency anemia (IDA) regardless of the underlying cause. The study being reported , IDA-301, compared Feraheme treatment to placebo and enrolled 808 patients at 136 sites in the US, Canada, India, Latvia, Hungary, and Poland. The patients enrolled in the study had a history of unsatisfactory response to, or could otherwise not tolerate, oral iron therapy. Patients in this study had IDA associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes. Feraheme demonstrated superiority on all primary efficacy endpoints evaluated in this study. The efficacy and safety of Feraheme in this study were comparable to that reported earlier this year in the IDA-302 study, the phase III IDA study comparing Feraheme to iron sucrose. The IDA-301 study was a double-blind, placebo-controlled trial that randomized patients 3:1 to receive a one gram IV course of Feraheme or placebo, and it was powered to demonstrate superiority on efficacy. In this study, 608 patients were treated with Feraheme and 200 received placebo, with the demographics and all baseline parameters well balanced between the two treatment groups. Full Article
AMAG Pharmaceuticals Inc Appoints William Heiden as President and Chief Executive Officer
AMAG Pharmaceuticals Inc announced the appointment of William K. Heiden as president and chief executive officer (CEO), effective May 14, 2012. Frank E. Thomas, who has served as interim CEO of the Company since November 2011, will return to his role of executive vice president and chief operating officer of AMAG. Full Article
AMAG Pharmaceuticals Inc Issues FY 2012 Revenue Guidance In Line With Analysts' Estimates-Conference Call
AMAG Pharmaceuticals Inc announced that including the expected revenues from partnership with Takeda, it expects total revenues in fiscal 2012 of between $79 million and $83 million. Full Article
Austria's B&C makes 23.40 eur takeover offer for AMAG
FRANKFURT, March 11 - Austrian investment group B&C Industrieholding GmbH said it will make a mandatory takeover offer of 23.40 euros to shareholders in aluminium group AMAG .
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