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December 4, 2012
06:12 EDTAMGN, NSANY, MSFT, GSK, HMC, AAPL, THLD, TM, INTC, FIATY, F, VLKAY, GMOn the Fly: Periodicals Wrap-Up
WALL STREET JOURNAL: As U.S. companies hold near record amounts of cash, many are surprisingly cash poor at home. That means there could be unseen limits on their ability to pay dividends and buy back shares, the Wall Street Journal reports...In November, U.S. sales of cars and light trucks were the strongest in over four years, jumping 15% to 1.14M compared with a year ago. The seasonally adjusted annualized sales rate was 15.5M, the highest since January 2008, according to Autodata, the Wall Street Journal reports...REUTERS: Fed bankers appear satisfied with their latest monetary stimulus, but there's some disagreement over how strongly to continue purchasing bonds. Boston Fed President Rosengren said there was a "strong case" for the Fed to stay the course, while St. Louis Fed President Bullard said they shouldn’t replace its expiring 'Operation Twist' program on a dollar-for-dollar basis, Reuters reports...U.S. rail and trucking companies are making big investments on both sides of the border with Mexico to capitalize on booming trade between the two countries, Reuters reports...BLOOMBERG: Four experimental cancer treatments that may one day help gravely ill children are facing review by U.S. pediatric advisers. The medicines from GlaxoSmithKline (GSK), Amgen (AMGN) Threshold (THLD) and Boehringer Ingelheim have the potential to treat children with a variety of tumors and fast-spreading leukemia, Bloomberg reports...The move by Microsoft (MSFT) and Intel (INTC) to combat Apple’s (AAPL) iPad in the $63.2B tablet market is getting off to a slow start, Bloomberg reports.
News For GM;F;FIATY;VLKAY;HMC;NSANY;TM;GSK;AMGN;THLD;MSFT;INTC;AAPL From The Last 14 Days
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December 8, 2014
16:00 EDTAAPLOptions Update; December 8, 2014
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13:32 EDTGSKEpizyme announces results for PRMT5 inhibitor
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13:21 EDTMSFTMicrosoft files appeal in case on customer data in Ireland
Microsoft said on its blog that it has filed an appeal in its ongoing case challenging a U.S. government search warrant for customer data stored in Ireland. Microsoft said it filed the appeal after a U.S. district court judge rejected the company’s argument that the warrant is illegal because it calls for the seizure of emails stored outside the United States. Reference Link
13:16 EDTAAPLApple trades off session lows, levels to watch
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12:40 EDTMSFTOn The Fly: Midday Wrap
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11:10 EDTVLKAY, TM, HMC, GM, F, NSANYVolkswagen sees challenging developments continuing for rest of year
Volkswagen (VLKAY) said, “The challenging developments on markets worldwide – above all in Eastern Europe and South America – will continue for the remainder of this year. The Volkswagen Passenger Cars brand handled these challenges successfully during the course of the year, but was not entirely immune to their impact.” Other publicly traded companies in the passenger automotive space include Fiat Chrysler (FCAU), Ford (F), General Motors (GM), Honda (HMC), Nissan (NSANY), and Toyota (TM).
11:09 EDTVLKAYVolkswagen reports passenger car deliveries up 2% to 5.6M in year-to-November
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10:44 EDTMSFTDigital River grants Microsoft extestion to decide on renewing pact
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10:04 EDTMSFTAccenture and Microsoft launch hybrid cloud platform
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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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08:07 EDTFFord management to meet with UBS
Meeting to be held in Boston on December 8 hosted by UBS.
06:37 EDTAAPLApple rumored to be launching 4-inch iPhone in 2015, Times of India reports
Apple is rumored to be developing a new iPhone with a 4-inch display, The Times of India reports, citing a report from The Electronic Times of Taiwan. According to supply chain sources, the device will launch in 2H15. Reference Link
06:22 EDTAAPLApple price target raised to $135 from $120 at Citigroup
Citigroup raised its earnings estimates for Apple after its field work indicated consumers are increasingly buying the higher memory iPhone 6 and 6+. Citi expects purchasing trends towards higher memory devices to drive stronger sales and margins. It believes consensus estimates are yet to factor in this development. The firm raised its price target for Apple shares to $135 from $120 and keeps a Buy rating on the name. Shares of phone maker closed Friday down 49c to $115.
06:15 EDTAAPLLenovo shipments expected to lead Samsung by 9M in 2015, DigiTimes reports
Lenovo (LNVGY) is estimated to beat Samsung (SSNLF) in mobile device shipments in 2015 by about 9M units, reports DigiTimes Research. Lenovo is set to beat Samsung by about 1M units in 2014 and become the second largest mobile computing device brand vendor worldwide behind Apple (AAPL). DigiTimes Research says Lenovo and Samsung plan to focus on maintaining tablet shipments as demand weakens in 2015. Reference Link
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
16:48 EDTTHLDThreshold Pharmaceuticals announces data from TH-302 study
Threshold Pharmaceuticals announced new preliminary data from the Phase 2 component of an ongoing company-sponsored Phase 1/2 trial of TH-302, the company's lead investigational anticancer drug, in combination with the proteasome inhibitor bortezomib, Velcade, and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma. The median number of prior therapies was 8. The recommended phase 2 dose of TH-302 was determined to be 340 mg/m2 and no dose limiting toxicities were observed at this dose level. Partial responses were observed in 2 of 7 evaluable patients overall and 2 of 4 evaluable patients at the recommended phase 2 dose of TH-302. These data are being presented today at the 56th ASH Annual Meeting and Exposition in San Francisco, California.
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 EDTAMGN, THLDAmerican Society of Hematology to hold a meeting
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