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January 16, 2014
09:12 EDTSRPT, APO, YHOO, HPQ, AMRN, AMGN, NUS, CEC, JCP, BBY, CSX, ILMN, BLK, SCHW, C, UNHOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Charles Schwab (SCHW), up 3%... BlackRock (BLK), up 1.5%. ALSO HIGHER: CEC Entertainment (CEC), up 13% after acquired by Apollo (APO) affiliate for $54 per share... HP (HPQ), up 2% after upgraded at BofA Merrill Lynch... Sarepta Therapeutics (SRPT), up 16% after announcing that data from a study of eteplirsen demonstrates continued stability in walking test... Illumina (ILMN), up 4.8% after in agreement with Amgen (AMGN) to develop oncology companion diagnostic test. DOWN AFTER EARNINGS: Citigroup (C), down 2.6%... CSX (CSX), down 6%.... UnitedHealth (UNH), down 0.5%. ALSO LOWER: Best Buy (BBY), down 30% after reporting domestic Holiday same-store sales fell 0.9%... Yahoo (YHOO), down 2% after COO Henrique de Castro to leave company effective January 16 after reportedly clashing with CEO Mayer... J.C. Penney (JCP), down 3.9% after announcing plans to close 33 underperforming stores and cut 2K jobs... after reporting earnings and revenue that just slightly missed estimates... Nu Skin (NUS), down 16.3% after responding to People's Daily article that called it a "pyramid scheme"... Amarin (AMRN), down 9.6% after the FDA delayed its ANCHOR SPA appeal, shares downgraded at MKM Partners.
News For BBY;HPQ;C;JCP;YHOO;SCHW;CEC;APO;BLK;NUS;SRPT;ILMN;AMGN;UNH;CSX;AMRN From The Last 14 Days
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December 8, 2014
16:55 EDTCLone Star joins Springleaf as bidder for Citigroup OneMain unit, Bloomberg says
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16:24 EDTAMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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16:00 EDTCOptions Update; December 8, 2014
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15:49 EDTNUSNu Skin to host investor day
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15:40 EDTCLone Star joins Springleaf as bidder for Citigroup OneMain unit, Bloomberg says
14:31 EDTNUSNu Skin December volatility elevated into investor day
Nu Skin December weekly call option implied volatility is at 84, December is at 56, January is at 50, March is at 52; compared to its 26-week average of 48 according to Track Data, suggesting large near term price movement into company hosted investor day on December 12.
11:58 EDTAPOApollo Global to host investor day
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10:00 EDTBLKOn The Fly: Analyst Downgrade Summary
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09:27 EDTBLKBlackRock downgraded to Neutral at Susquehanna
As previously reported, Susquehanna downgraded BlackRock to Neutral from Positive citing weaker emerging markets and reduced expectations for active equity flow in 2015. Susquehanna maintained its $365 price target on BlackRock shares.
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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07:28 EDTHPQFBN Securities to hold a bus tour
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07:03 EDTBLKBlackRock downgraded to Neutral from Positive at Susquehanna
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06:35 EDTCValue of Wall Street's M&A bankers has risen, NY Times says
The value of Wall Street's bankers who advise large companies seems to be increasing, while traders are becoming less valuable, according to The New York Times. Bankers who work on M&A deals are expecting their bonuses to increase, while traders anticipate that their compensation will drop, the newspaper added. Furthermore, banks seem to be going the extra mile to hire top notch bankers, the newspaper stated. Publicly traded large banks include Bank of America (BAC), Citigroup (C), Goldman Sachs (GS), JPMorgan (JPM), Morgan Stanley (MS), U.S. Bancorp (USB) and Wells Fargo (WFC). Reference Link
06:21 EDTCDeadline for Petsmart bidders extended as lenders put on leash, NY Post reports
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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
15:53 EDTHPQHP shares could gain 15%, Barron's says
HP shares could gain 15% to $45.00 per share as the company splits its enterprise business from PCs and printer business, by next October, Barron's argues in a follow up article. Reference Link
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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