New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
July 3, 2014
09:03 EDTRGDO, ISCA, NQ, AMGN, PCAR, LULU, BIND, APP, PETMOn The Fly: Pre-market Movers
HIGHER: PetSmart (PETM), up 16% after activist investor Jana Partners disclosed that it has acquired a 9.9% stake and intends to have talks with PetSmartís board of directors and management regarding a review of strategic alternatives including exploring a sale... American Apparel (APP), up 9.6% after deposed CEO Dov Charney reportedly surrendered his entire stake and voting rights in the retailer to hedge fund Standard General, according to Reuters... International Speedway (ISCA), up 4% after reporting Q2 adjusted EPS and revenue that beat expectations... PACCAR (PCAR), up 4% after research reports said Daimler's (DDAIY) truck chief claimed to have been told that Volkswagen (VLKAY) wants to take over the truck maker, though a spokesman for Volkswagen told Dow Jones that there is "no truth" to the reports that it is planning an acquisition bid... lululemon (LULU), up 3.7% after The Wall Street Journal reported last night, citing people familiar with the situation, that the company's founder has been talking to private equity firms through advisers about taking the company private. LOWER: Regado Biosciences (RGDO), down 54% after announcing that the Data Safety Monitoring Board has initiated an unplanned review of data from the REGULATE-PCI trial and the stock was downgraded to Underperform from Outperform at Wedbush... NQ Mobile (NQ), down 21.5% after reporting that its auditor, PwC, has requested to expand the scope of its 2013 audit work and that the audit committee chair is stepping down from the board... BIND Therapeutics (BIND), down 13% after announcing Amgen (AMGN) will not be exercising its development option under the companies' collaborative research program.
News For PETM;LULU;NQ;APP;PCAR;ISCA;BIND;AMGN;RGDO From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | 4 | 5 | all recent news | >>
December 9, 2014
07:09 EDTLULUlululemon's Q3 results could mark an inflection point, says Barclays
Subscribe for More Information
05:41 EDTLULUlululemon upgraded to Outperform from Market Perform at Wells Fargo
Subscribe for More Information
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
Subscribe for More Information
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
Subscribe for More Information
06:21 EDTPETMDeadline for Petsmart bidders extended as lenders put on leash, NY Post reports
Subscribe for More Information
06:12 EDTLULUStocks with implied volatility above IV index mean; LULU ACHN
Stocks with implied volatility above IV index mean; lululemon (LULU) 53, Achillion (ACHN) 216 according to iVolatility.
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
Subscribe for More Information
14:10 EDTAMGNAmerican Society of Hematology to hold a meeting
Subscribe for More Information
December 5, 2014
06:18 EDTNQStocks with implied volatility above IV index mean; NQ EBAY
Stocks with implied volatility above IV index mean; NQ Mobile (NQ) 144, eBay (EBAY) 20 according to iVolatility.
December 4, 2014
15:36 EDTPETMPetSmart deal may be pressured by leveraged loan guidelines, Reuters says
Regulators took a hard line at a recent meeting with bankers about the implementation of leveraged lending guidelines, which has raised questions about whether the auction for PetSmart could be derailed by an absence of financing, according to Reuters. Reference Link
14:21 EDTLULULululemon Athletica volatility elevated into Q3 and outlook
Subscribe for More Information
13:26 EDTAMGNAmgen to host investor meeting
Investor meeting to be held in conjunction with the American Society of Hematology's 56t Annual Meeting in San Francisco on December 8 at 3 pm. Webcast Link
10:08 EDTBINDOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Anglo American (AAUKY) downgraded to Underperform from Buy at BofA/Merrill... Archer Daniels (ADM) downgraded to Hold from Buy at Miller Tabak... AuRico Gold (AUQ) downgraded to Underweight from Equal Weight at Morgan Stanley... BHP Billiton (BHP) downgraded to Neutral from Buy at BofA/Merrill... BIND Therapeutics (BIND) downgraded at Credit Suisse... BRF S.A. (BRFS) downgraded to Neutral from Buy at Goldman... CIRCOR (CIR) downgraded to Hold from Buy at BB&T... DISH (DISH) downgraded to Underweight from Equal Weight at Barclays... Enerplus (ERF) downgraded to Sector Performer from Outperformer at CIBC... Gildan Activewear (GIL) downgraded to Hold from Buy at GMP Securities... Kindred Biosciences (KIN) downgraded to Hold from Buy at Craig-Hallum... Nevsun Resources (NSU) downgraded to Neutral from Buy at UBS... Public Storage (PSA) downgraded at KeyBanc... Rio Tinto (RIO) downgraded to Underperform from Buy at BofA/Merrill... SeaChange (SEAC) downgraded to Hold from Buy at Noble Financial... Thor Industries (THO) downgraded at BMO Capital... Tupperware Brands (TUP) downgraded to Underperform from Market Perform at BMO Capital... UTi Worldwide (UTIW) downgraded at Stifel... Vale (VALE) downgraded to Neutral from Buy at BofA/Merrill... Vermilion Energy (VET) downgraded to Sector Performer from Outperformer at CIBC... Wal-Mart (WMT) downgraded to Neutral from Buy at UBS.
08:40 EDTLULUlululemon coverage assume with an Outperform at Wedbush
Wedbush assumed coverage on lululemon with an Outperform rating from a Neutral rating and $57 price target. The firm sees shares moving higher from catalysts that include improving top line trends and comps, margin uside form seasonal products and supply chain efficiencies, international growth, and M&A speculation.
06:29 EDTBINDBIND Therapeutics downgraded at Credit Suisse
As previously reported, Credit Suisse downgraded BIND Therapeutics to Neutral from Outperform. The firm said recent BIND-014 data does not demonstrate a visible path forward and active agents belong to an unproven drug class. Price target lowered to $10 from $20.
06:05 EDTBINDBIND Therapeutics downgraded to Neutral from Outperform at Credit Suisse
1 | 2 | 3 | 4 | 5 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use