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Stock Market & Financial Investment News

News Breaks
July 30, 2014
17:12 EDTGT, HSP, PWE, GNW, EW, GRMN, AMGN, TWTROn The Fly: Closing Wrap
Stocks on Wall Street began the session in positive territory following a better than expected GDP growth estimate for the second quarter, but were unable to hold their initial gains. The averages reversed early in the session and eventually crossed into negative territory, as investors chose to wait for the Fedís rate decision and to listen to the accompanying statements. The Fed kept rates the same, said inflation was tracking towards their goals, and continued to reduce their planned purchases of bonds, which was all generally in keeping with expectations. The market initially revived, but then settled back into the range it was in before the Fed's release and limped into the close. ECONOMIC EVENTS: The Commerce Department estimated that U.S. Gross Domestic Product grew at a seasonally adjusted annual rate of 4.0% in the second quarter, easily beating expectations for a growth rate of 3.0%. ADP reported private payrolls climbed 218K in July, which was a bit below the 238K forecast. The Federal Reserve wrapped up its two-day Federal Open Market Committee meeting and, as expected, decided to reduce its monthly asset purchases by $10B next month. The Fed will buy $10B of mortgage-backed securities in August, down from $15B in July, and will buy $15B of longer-term Treasury securities next month, down from $20B previously. The committee reaffirmed its view that highly accommodative monetary policies are still appropriate and maintained its 0% to 0.25% target range for the federal funds rate. Additionally, the leaders of the G-7 issued a joint statement that they "remain ready to further intensify the costs" to Russia if it does not change its course regarding Ukraine. COMPANY NEWS: Shares of Twitter (TWTR) surged $7.71, or 19.98%, to $46.30 after the social network operator's second quarter results beat analysts' consensus estimates and it raised its fiscal year 2014 revenue and adjusted EBITDA forecasts. Following last night's report, Bank of America Merrill Lynch upgraded Twitter to Buy from Neutral, while the stock was also upgraded at FBN Securities, UBS and Cowen. MAJOR MOVERS: Among the notable gainers following their earnings reports were Edwards Lifesciences (EW), which gained $8.44, or 10.0%, to $92.88, Hospira (HSP), which rose $4.31, or 8.3%, to $56.21, and Amgen (AMGN), which advanced $6.70, or 5.43%, to $130.01. Among the notable gainers following their earnings reports were Genworth Financial (GNW), which fell $2.28, or 14.02%, to $13.98, Goodyear Tire (GT), which declined $2.14, or 7.76%, to $25.45, and Garmin (GRMN), which dropped $3.17, or 5.51%, to $54.41. Also lower was Penn West Petroleum (PWE), which fell $1.30, or 14.21%, to $7.85 after it announced that the Audit Committee of the company's Board of Directors is conducting a voluntary, internal review of certain of the company's accounting practices. INDEXES: The Dow dropped 31.75, or 0.19%, to 16,880.36, the Nasdaq gained 20.20, or 0.45%, to 4,462.90, and the S&P 500 added 0.12, or 0.01%, to 1,970.07.
News For TWTR;EW;HSP;AMGN;GNW;GT;GRMN;PWE From The Last 14 Days
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December 8, 2014
17:54 EDTHSPFour Cubist Cubicin patents invalidated as Hospira wins ruling, Bloomberg says
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17:30 EDTHSPMerck shares lower after reports of judge decision in Cubist/Hospira case
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17:03 EDTHSPJudge may have found in favor of Hospira in Cubist case,CNBC's Meg Tirrell says
CNBC's Meg Tirrell said in a tweet: "Whoa. $CBST Hospira decision out -- "appears judge may have found in favor of Hospira on several points," ISI's @MarkSchoenebaum says." Reference Link
16:24 EDTAMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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14:24 EDTTWTRRumor: Twitter moves off lows amid speculation Apple may take a stake
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13:38 EDTTWTRTwitter breaks to lows of the day, levels to watch
The shares are down over 6.7% to $35.89 at time of writing. Resistance is now at former support at $36.38. Support is now at $35.06.
11:21 EDTTWTRTwitter volatility low as shares pullback to four-month low
Twitter December weekly call option implied volatility is at 51, December is at 46, January at 43; compared to its 26-week average of 54 according to Track Data, suggesting decreasing price movement
10:16 EDTTWTRTwitter falls to session lows, levels to watch
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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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08:21 EDTHSPMerck says looked at all risks, including patent litgation, before Cubist deal
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08:16 EDTEWEdwards Lifesciences announces investments in CardioKinetix
Edwards made a structured investment in CardioKinetix, a privately held medical device company pioneering a catheter-based treatment for heart failure. This transaction increases Edwards' existing minority interest in CardioKinetix and provides an option to purchase the remaining outstanding shares for a future payment, plus additional milestone payments based on future regulatory and reimbursement approvals. In the second investment, the company acquired intellectual property that broadens its transcatheter mitral valve development efforts. Additional details of both investments were not disclosed.
08:15 EDTEWEdwards Lifesciences sees FY15 EPS $3.90-$4.10, consensus $3.96
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08:12 EDTEWEdwards Lifesciences backs FY14 EPS $3.33-$3.39, consensus $3.39
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06:05 EDTEWEdwards Lifesciences to host investor meeting
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06:00 EDTTWTRTwitter's former head of product leaving company, Re/code reports
Daniel Graf, who was replaced by Kevin Weil as head of product last month, is leaving the company, Re/code reports. 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
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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