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August 13, 2014
18:55 EDTAMGN, CNAT, KND, NDLS, AZPN, CSCOOn The Fly: After Hours Movers
UP AFTER EARNINGS: Aspen Technology (AZPN), up almost 3% after reporting better than expected Q4 results and giving Q1 and FY15 guidance on its earnings conference call. ALSO HIGHER: Kindred Healthcare (KND), up more than 1% after Point72 reported a 5.1% passive stake in the company. DOWN AFTER EARNINGS: Cisco Systems (CSCO), down 1.2% after reporting Q4 results, giving Q1 guidance, and announcing that it is cutting 8% of its workforce... Noodles & Company (NDLS), down 21.2% after reporting Q2 results and "tempering" its FY14 outlook... Conatus Pharmaceuticals (CNAT), down 13.6% after reporting Q2 results and announcing it is deferring the results of its NAFLD/NASH clinical trial to 1Q15. ALSO LOWER: Amgen (AMGN), down 2.15% after announcing the Phase 3 Kyprolis FOCUS clinical trial did not meet its primary endpoint.
News For AZPN;KND;CSCO;NDLS;CNAT;AMGN From The Last 14 Days
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December 10, 2014
07:36 EDTCSCOCisco to hold a conference
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December 9, 2014
10:23 EDTCSCOOn The Fly: Analyst Initiation Summary
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08:19 EDTCSCOCisco outlook has improved, says RBC Capital
RBC Capital believes that Cisco's negative catalysts are diminishing. The firm thinks the stock is being boosted by its successful efforts to keep its gross margin at or above the 61%-62% range, as well as a rebound in its switching business. RBC recommends buying the stock on dips and keeps a $29 price target and Outperform rating on the name.
07:44 EDTAMGNAmerican Association for Cancer Research to hold a symposium
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07:41 EDTCSCOBarclays to hold a conference
Global Technology Conference is being held in San Francisco on December 9-10 with webcasted company presentations to begin on December 9 at 10:40 am; not all company presentations may be webcasted. Webcast Link
06:39 EDTCSCOCisco initiated with an Outperform at Wedbush
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05:40 EDTAMGNAmgen presents new BLINCYTO Phase 2 study data at ASH meeting
Amgen announced that new data from a pivotal Phase 2 study evaluating BLINCYTO for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, or ALL was presented at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. In one analysis from the '211 study, 40% of patients treated with BLINCYTO who achieved a complete remission, or CR, or complete remission with partial hematologic recovery, or CRh, were enabled to proceed to allogeneic hematopoietic stem cell transplant, or HSCT. Additionally, a secondary analysis from the study found that 82% of patients who had a CR or CRh also had a minimal residual disease, or MRD, response, a measure used to predict disease recurrence in patients with ALL. In one analysis of the '211 study, 40% of patients treated with BLINCYTO who achieved a CR or CRh were enabled to proceed to HSCT, including both patients who had received prior HSCT and patients who had not received prior HSCT. A secondary analysis of the study demonstrated that, among patients receiving BLINCYTO who had a CR or CRh and had evaluable MRD data, 82% had an MRD response, with 70% of those patients achieving a complete MRD response. Median overall survival was longer among patients who had a CR or CRh and an MRD response compared to patients who didn't have an MRD response.
December 8, 2014
16:24 EDTAMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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12:40 EDTCSCOUS Supreme Court to hear appeal in patent fight with Cisco
The U.S. Supreme Court has agreed to hear an appeal of a controversial appeals court decision that set aside a $63.8M patent infringement verdict won by The Woodlands, Texas-based Commil USA LLC against Cisco
09:09 EDTAMGNAmgen announces FDA approval for XGEVA
Amgen announced that the FDA has approved a new indication for XGEVA for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. HCM is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis.1,2 The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death. The approval of XGEVA is based on positive results from an open-label, single-arm study, which enrolled patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with a response, defined as albumin-corrected serum calcium <11.5 mg/dLwithin 10 days after the first dose of XGEVA. Secondary endpoints included the proportion of patients who experienced a complete response (defined as CSC <10.8 mg/dL by day 10, time to response and response duration. The study achieved its primary endpoint with a response rate at day 10 of 63.6 percent in the 33 patients evaluated. The overall complete response rate was 63.6 percent. The estimated median time to response was nine days, and the median duration of response was 104 days.4,5
09:09 EDTAMGNAmgen announces FDA approval for XGEVA
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08:40 EDTCSCODeutsche Bank and Cisco to host a conference call
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08:02 EDTCSCOAruba says NHS replaces Cisco network with Aruba wireless infrastructure
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07:49 EDTCSCOArista Networks lawsuit not as threatening as believed, says SunTrust
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07:32 EDTCSCORaymond James to hold a conference
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07:03 EDTCSCOArista Networks patent resolution likely 2-3 years away, says Citigroup
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05:42 EDTAMGNSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
December 7, 2014
14:38 EDTAMGNAmgen announces new data from Phase 2 BLINCYTO immunotherapy study
Amgen announced new data from the Phase 2 BLAST study which evaluated the bispecific T cell engager, BiTE, immunotherapy BLINCYTO in patients with minimal residual disease, MRD, positive B-cell precursor acute lymphoblastic leukemia, ALL. In the study, 78% of patients who received BLINCYTO experienced a complete MRD response , a measure of eradication of residual disease at the molecular level, after one treatment cycle. Nearly all complete responses occurred within the first treatment cycle. The results from the BLAST study will be featured during the 56th American Society of Hematology Annual Meeting and Exposition press briefing on Saturday, December 6, at 10 a.m. PT and will be presented in an oral session at ASH on Monday, December 8, at 10:30 a.m. PT. "BLINCYTO is the most advanced of Amgen's BiTE immunotherapies, a new and innovative approach that helps the body's own immune system fight cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Achieving molecular complete remission is an important goal in the treatment of ALL, and the data presented at ASH demonstrates that BLINCYTO can produce deep responses in patients that have trace amounts of residual disease." MRD is a state of disease in which the microscopic analysis does not show malignant cells, but more sensitive techniques still detect disease at the molecular level. Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD. In addition to the majority of patients achieving a compete MRD response within one cycle of treatment, 80% achieved a complete MRD response across all cycles. Responses occurred in all subgroups including older patients and patients with high MRD level; no predictive factor for MRD response was identified. In the study, adverse events of all grades occurring in 20% or more patients included pyrexia, tremor, chills, fatigue, nausea, vomiting and diarrhea. Grade =3 AEs occurring in five percent or more patients included neutropenia , pyrexia and tremor. Two fatal AEs occurred on treatment: subdural hemorrhage and pneumonitis in conjunction with influenza. Treatment interruptions due to AEs occurred in 31% of patients.
14:18 EDTAMGNAmgen, Onyx announce detailed results from Phase 3 ASPIRE study of Kyprolis
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14:10 EDTAMGNAmerican Society of Hematology to hold a meeting
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