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December 10, 2012
11:18 EDTAMAGAMAG Pharmaceuticals announces new data from phase III trials of ferumoxytol
AMAG Pharmaceuticals announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology’s annual meeting in Atlanta, Georgia. The phase III trials evaluated the use of ferumoxytol in subjects with iron deficiency anemia, or IDA, regardless of the underlying cause of the anemia, who had failed or could not tolerate oral iron treatment. New data from an investigator-initiated study evaluating a one gram 15-minute infusion of ferumoxytol are also being presented at ASH; the current approved dosing of ferumoxytol is two 510 mg injections, three to eight days apart. Two poster sessions highlighted the safety and efficacy data from each of the phase III clinical trials: IDA-301 and IDA-302. In addition, an oral presentation contained patient-reported outcome data from IDA-301, which demonstrated a direct correlation between the rise in hemoglobin and improvement in patient-reported measures of fatigue. Data from these two clinical trials will be the foundation for AMAG’s supplemental new drug application in the United States. AMAG's sNDA will seek to expand the use of Feraheme for all adult iron deficiency anemia patients with a history of unsatisfactory use of oral iron. The company expects to submit the sNDA to the U.S. Food and Drug Administration this month. In the United States, Feraheme is currently indicated only for the treatment of iron deficiency anemia in adult CKD patients.
News For AMAG From The Last 14 Days
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November 23, 2015
08:11 EDTAMAGAMAG Pharmaceuticals responds to CRL from FDA for Makena
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November 19, 2015
12:19 EDTAMAGOn The Fly: Top stock stories at midday
Stocks have struggled for direction since the open and spent the morning moving in a narrow range. The Dow has held up fairly well considering the weakness seen in UnitedHealth (UNH), which has declined after the insurer cut its fiscal 2015 profit guidance, citing weakness in individual health insurance policies it markets through exchanges. Oil prices remain under pressure, with benchmark U.S. crude trading back below $42 per barrel. ECONOMIC EVENTS: In the U.S., initial jobless claims continued to hover around four-decade lows, with 271,000 first-time claims filed in the week ended November 14. The Philly Fed index rose 6.4 points to 1.9 in November, better than the forecast for a -0.5 reading. In Europe, minutes from the most recent European Central Bank policy meeting showed that some participants called for more stimulus amid deflation risks, weak oil prices and a sluggish recovery in the euro-area. In Asia, the Bank of Japan maintained its current pace of monetary stimulus, as widely expected. COMPANY NEWS: The shares of health insurer UnitedHealth and a number of other companies in the sector are falling after the Dow member lowered its profit outlook for this fiscal year, citing weakness in individual health insurance policies it markets through exchanges. UnitedHealth said it has pulled back on its marketing efforts for individual exchange products in 2016 and is "evaluating the viability of the insurance exchange product segment." Near noon, UnitedHealth fell about 5%, while Aetna (AET) declined nearly 6%, Humana (HUM) droped more than 3.5%, Anthem (ANTM) declined over 6% and Cigna (CI) slid 4%... Press reports indicate that talks between Pfizer (PFE) and Allergan (AGN) are heating up and that a deal is nearing, but simultaneously the U.S. government's rhetoric around the type of "inversion" deal the two pharmaceutical giants are discussing is getting ratcheted up as well. Last night, Bloomberg reported that Pfizer is nearing an agreement to acquire Allergan for $370 to $380 per share, citing people familiar with the matter. The two companies are aiming to announce a deal as early as Monday, sources told the publication. However, CNBC's David Faber reported, citing sources, that a deal will not be announced on Monday, but Pfizer and Allergan are in the "final innings" of merger talks. The deal will consist of all stock and Pfizer is likely to offer 11-plus shares per Allergan share, Faber noted. Amid the reports, Treasury Secretary Jacob Lew said that his department will release "targeted guidance" later this week meant to "deter and reduce further the economic benefits of corporate inversions" like the one being contemplated by the drugmakers... Square (SQ) completed its initial public offering of stock and rose about $4 per share to trade near $13 around noon after pricing last night at $9 per share. CEO Jack Dorsey, who leads both Square and Twitter (TWTR) as CEO, said in an interview following the opening that the teams behind him make him able to simultaneously hold both positions. Twitter rose about 1.4% to $26.25 in midday trading following Square's entry to the public markets. MAJOR MOVERS: Among the notable gainers was Keurig Green Mountain (GMCR), which rallied 22% after it reported better than expected quarterly earnings and guided for fiscal 2016. Also higher was (CTRP), which gained 19% after no fewer than three analysts raised their price target on the company's stock following upbeat fourth quarter earnings. Among the noteworthy losers was Kirkland's (KIRK), which fell 30% after the company reported downbeat quarterly earnings and provided lower than expected guidance. Also lower was AMAG Pharmaceuticals (AMAG), which lost over 8.5% after it received a complete response letter from the FDA for a single-dose vial of Makena, a treatment to reduce the risk of preterm birth in at-risk patients. In addition, Best Buy (BBY) fell 3% after it reported better than expected third quarter earnings but worse than expected same-store sales growth and also guided toward "near-flat" revenue for its domestic business in the holiday quarter. INDEXES: Near midday, the Dow was down 17.44, or 0.1%, to 17,719.72, the Nasdaq was up 2.36, or 0.05%, to 5,077.57, and the S&P 500 was down 3.67, or 0.18%, to 2,079.91.
09:16 EDTAMAGOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Keurig Green Mountain (GMCR), up 19%... (CTRP), up 11.8%... (CRM), up 5.4%... Perry Ellis (PERY), up 4%. ALSO HIGHER: Celladon (CLDN), up 55.9% after signing a merger agreement with Eiger BioPharmaceuticals... StemCells (STEM), up 45.7% after Phase II Pathway Study data shows motor improvement in SCI patients... UniPixel (UNXL), up 36.1% after receiving an initial mass production order from a Japanese PC manufacturer... Anavex Life Sciences (AVXL), up 16% after announcing preparation of regulatory filings based on guidance from FDA... Plug Power (PLUG), up 3.7% after securing Colruyt Group as its next GenDrive fuel cell customer in Europe. DOWN AFTER EARNINGS: Stage Stores (SSI), down 14.7%... JinkoSolar (JKS), down 7.5%... Best Buy (BBY), down 5.2%... Semtech (SMTC), down 7.5%. ALSO LOWER: AMAG Pharmaceuticals (AMAG), down 8.4% after receiving a complete response letter from the FDA its application seeking approval for a single-dose vial of Makena... Titan International (TWI), down 8.3% after being downgraded to Sell from Neutral at Goldman... Sunedison (SUNE), down 5.5% after Reuters reported that Blackstone (BX) is not interested in SunEdison investment.
November 18, 2015
17:44 EDTAMAGAMAG Pharmaceuticals receives CRL from FDA for single-dose vial of Makena
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