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July 15, 2013
19:14 EDTAMGNInterim results from Amgen Phase 2 study published
Amgen announced the Lancet Oncology published planned interim results from an international, open-label, Phase 2 clinical trial that is evaluating Xgeva in adults and skeletally mature adolescents diagnosed with giant cell tumor of bone. The study's primary endpoint is the safety profile of Xgeva. Secondary endpoints are the time to disease progression and the proportion of patients without any surgery at six months. Based on the investigators' interim assessment, 96% of patients with surgically unsalvageable GCTB had no disease progression after a median follow-up of 13 months. In those with salvageable GCTB whose surgery was associated with severe morbidity, 74% of patients required no surgery, and 62% of patients who had surgery underwent a less morbid procedure than planned. Overall, 72% of patients had objective tumor response, per protocol defined criteria, including 25% of patients who had an objective tumor response according to modified response evaluation criteria in solid tumors. The overall safety profile was found to be consistent with the known safety profile of Xgeva in patients with advanced cancer. Osteonecrosis of the jaw was reported in 1% of patients. Hypocalcemia adverse events, all non-serious, were reported in 5% of patients. The most common severe adverse events were low phosphate levels, back pain, pain in extremity, depression, musculoskeletal pain and anemia. Serious adverse events were reported in 9% of patients. No treatment-related deaths were reported.
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January 27, 2015
17:00 EDTAMGNAmgen Q4 Enbrel sales grew 19% quarter over quarter
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16:15 EDTAMGNAmgen submits applications in US and Europe for Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced the submission of a supplemental New Drug Application,sNDA to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for Kyprolis for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. In the U.S., the sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. In the European Union, Kyprolis received orphan drug designation and the MAA has been granted accelerated assessment. The sNDA and MAA are based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data. "Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals, Inc. "The U.S. and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma."
16:06 EDTAMGNAmgen trades higher after hours, levels to watch
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16:04 EDTAMGNAmgen backs FY15 EPS view $9.05-$9.40, consensus $9.29
Backs FY15 revenue view $20.8B-$21.3B, consensus $20.87B.
16:03 EDTAMGNAmgen reports Q4 EPS $2.16, consensus $2.05
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15:35 EDTAMGNNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Apple (AAPL), consensus $2.60; AT&T (T), consensus 55c; Amgen (AMGN), consensus $2.05; Yahoo (YHOO), consensus 29c; ACE (ACE), consensus $2.29; Stryker (SYK), consensus $1.45; Western Digital (WDC), consensus $2.10; Electronic Arts (EA), consensus 92c; Juniper (JNPR), consensus 31c; Total System Services (TSS), consensus 53c; Freescale Semiconductor (FSL), consensus 33c; Amdocs (DOX), consensus 81c; VMware (VMW), consensus $1.07; International Game Technology (IGT), consensus 25c; United States Steel (X), consensus 87c; Cytec (CYT), consensus 61c.
12:57 EDTAMGNEarnings Preview: Amgen's Kyprolis, Prolia sales key for Q4 results
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January 21, 2015
10:16 EDTAMGNLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 15, 2015
16:04 EDTAMGNAmgen announces new data from Phase 2 PEAK, Phase 3 PRIME studies
Amgen announced new data from the Phase 2 PEAK and Phase 3 PRIME studies that support the first-line use of Vectibix in combination with Folfox, an oxaliplatin-based chemotherapy regimen, in patients with wild-type RAS metastatic colorectal cancer. In an exploratory analysis from the PEAK study, treatment with Vectibix compared to Avastin resulted in a "significantly higher proportion" of patients with earlier tumor shrinkage at week eight, 64% vs. 45%, respectively, and among responding patients, a longer duration of response, 11.4 vs. 8.5 months, respectively, and greater depth of response . Overall response rates appeared to be similar between Vectibix and Avastin. This is consistent with observed overall survival and progression-free survival (PFS) rates, and with data previously reported, Amgen said. It added, "While the primary analysis from PEAK showed similar ORR between the Vectibix- and bevacizumab-based regimens, this exploratory analysis demonstrates that Vectibix produces early, sustained anti-tumor activity, which may in part explain the OS and PFS benefits seen with Vectibix versus bevacizumab in this trial."
07:59 EDTAMGNAmerican Society of Clinical Oncology to hold a symposium
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