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Stock Market & Financial Investment News

News Breaks
February 11, 2013
10:14 EDTKMB, PRI, PDCE, SCHW, CMA, NR, BAS, TS, S, POWI, ELN, ALNY, KEY, LNKD, ESV, GMCR, SIAL, PMC, FOSL, AMGN, BHI, LUFKOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Alnylam (ALNY) downgraded to Hold from Buy at MLV Equity... Charles Schwab (SCHW) downgraded to Sell from Neutral at Citigroup... Elan (ELN) downgraded to Neutral from Buy at UBS... Fossil (FOSL) downgraded to Hold from Buy at Benchmark Co... PDC Energy (PDCE) downgraded to Neutral from Buy at SunTrust... PharMerica (PMC) downgraded to Sector Perform from Outperform at RBC Capital... Power Integrations (POWI) downgraded to Hold from Buy at Deutsche Bank... Primerica (PRI) downgraded to Market Perform from Outperform at Keefe Bruyette... Sigma-Aldrich (SIAL) downgraded to Sell from Neutral at UBS... Sprint (S) downgraded to Neutral from Overweight at Atlantic Equities... Kimberly Clark (KMB) downgraded to Underweight from Equal Weight at Barclays... Green Mountain (GMCR) downgraded to Neutral from Buy at Dougherty... Tenaris (TS) downgraded to Hold from Buy at Dahlman Rose... Lufkin (LUFK) downgraded to Hold from Buy at Dahlman Rose... Ensco (ESV) downgraded to Hold from Buy at Dahlman Rose... Basic Energy (BAS) downgraded to Hold from Buy at Dahlman Rose... Baker Hughes (BHI) downgraded to Hold from Buy at Dahlman Rose... LinkedIn (LNKD) downgraded to Market Perform from Outperform at Northland Securities... Newpark Resources (NR) downgraded to Hold from Buy at Dahlman Rose... Amgen (AMGN) downgraded to Market Perform from Outperform at William Blair... KeyCorp (KEY) downgraded at Stifel Nicolaus... Comerica (CMA) downgraded at Stifel Nicolaus.
News For ALNY;SCHW;FOSL;ELN;PDCE;PMC;POWI;PRI;SIAL;S;KMB;GMCR;TS;LUFK;ESV;BAS;BHI;LNKD;NR;AMGN;KEY;CMA From The Last 14 Days
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December 9, 2014
10:23 EDTKEYOn The Fly: Analyst Initiation Summary
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09:21 EDTPDCEOn The Fly: Pre-market Movers
UP AFTER EARNINGS: AutoZone (AZO), up 3.8%... Burlington Stores (BURL), up 3.3%. ALSO HIGHER: bluebird bio (BLUE), up 56.5% after price target raised at Piper Jaffray and SunTrust... Camtek (CAMT), up 6.7% after being awarded a $2.8M order from a semiconductor manufacturer... PDC Energy (PDCE), up 5.8% after providing fiscal 2015 production guidance... Mast Therapeutics (MSTX), up 3.1% after reporting that it will begin recruiting patients for MST-188 study in first half of fiscal 2015... Idera Pharmaceuticals (IDRA), up 1.4% after announcing data for its lead product candidate, IMO-8400. DOWN AFTER EARNINGS: UTi Worldwide (UTIW), down 10.8%... CONN'S (CONN), down 35.9% after reporting third quarter results, withdrawing fiscal 2015 guidance, stating that there is no timetable set for completion of strategic alternatives, and announcing the departure of its CFO. ALSO LOWER: Apple (AAPL), down 1.6% after Pacific Crest says that weak iPad demand could cause Apple to miss estimates and following a Wall Street Journal report that a judge denied Apple's efforts to throw out iPod pricing lawsuit... Allied Nevada Gold (ANV), down 30.1% after announcing pricing of common stock and warrant offering... United Continental (UAL), down 2.7% after reporting November traffic.
07:44 EDTAMGNAmerican Association for Cancer Research to hold a symposium
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06:43 EDTKEYKeyCorp initiated with a Buy at Guggenheim
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06:38 EDTALNYAlnylam to host conference call
Conference call to discuss Phase 1 data from ALN-AT3, in development for the treatment of hemophilia will be held on December 9 at 8 am. Webcast Link
06:03 EDTBASBasic Energy reports November well servicing rig count unchanged at 421
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05:47 EDTALNYAlnylam reports poisitve initial results for ALN-AT3
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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
17:32 EDTPDCEPDC Energy outlines 2015-2016 hedge and financial positioning
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17:30 EDTPDCEPDC Energy sees FY15 CapEx about $557M, FY15 production 13.8M-14.5M Boe
PDC's capital budget for 2015 is approximately $557M, a decrease of 14% compared to its 2014 capital budget. The company's 2015 budget includes $526M of development capital and $31M for lease maintenance, exploration and other expenditures. The 2015 capital budget is focused on organic growth opportunities in PDC's Inner and Middle core areas of the Wattenberg Field. The Company estimates net production volumes for 2015 will be between 13.8M-14.5M barrels of oil equivalent and expects production growth throughout the year. The company anticipates a commodity mix of approximately 45% crude oil, 20% natural gas liquids and 35% natural gas. The commodity mix reflects the company's increased focus on allocating capital towards its highest-value drilling opportunities in both the Inner and Middle core areas of the Wattenberg Field. For 2015, the company projects it will drill approximately 90% of its wells in the Inner and Middle Core areas, up from about 67% in those areas in 2014. PDC estimates its 2014 production exit rate to be approximately 32,500 Boe per day and its full-year 2014 production volumes to be within its guidance range of 9.3 to 9.5 MMoe. The Company's 2015 production exit rate is anticipated to be approximately 46,500 Boe per day
16:24 EDTAMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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14:56 EDTSMDC Partners climbs for third day after making announcement on CRM unit
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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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07:40 EDTPDCEMany E&P target prices lowered at SunTrust
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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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13:13 EDTALNYAlnylam files clinical trial application for ALN-CC5
Alnylam Pharmaceuticals announced that it has filed a Clinical Trial Application, CTA, with the U.K. Medicines and Healthcare products Regulatory Agency, MHRA, to initiate a Phase 1/2 clinical trial with ALN-CC5, a subcutaneously administered investigational RNAi therapeutic targeting complement component C5 for the treatment of complement-mediated diseases. As per the CTA filing, the intended clinical study of ALN-CC5 will be performed in normal human volunteers and, then, in patients with paroxysmal nocturnal hemoglobinuria, PNH. Following approval of the CTA, the company expects to initiate the Phase 1/2 study in early 2015, with initial data expected to be reported in mid-2015. In addition, Alnylam scientists presented new pre-clinical data at the 56th Annual Meeting of the American Society of Hematology. Amongst other reported research findings, new data showed an up to 99.2% knockdown of serum C5 and up to 96.2% inhibition of serum hemolytic activity in non-human primates, NHPs, with continued dosing for over seven months.
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