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March 13, 2013
11:52 EDTHNZ, EXAS, SPPI, ZIOP, WHXOptions with increasing implied volatility: ZIOP EXAS WHX SPPI HNZ
News For ZIOP;EXAS;WHX;SPPI;HNZ From The Last 14 Days
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November 27, 2015
13:22 EDTEXASOn The Fly: Top stock stories for Friday
Stocks on Wall Street were mixed following the short Black Friday session. In addition to periodic checks on traffic at malls and big box retailers, the day's media coverage was dominated by discussion of Disney's disclosure that subscribers for ESPN have dropped about 3% from last year's levels. ECONOMIC EVENTS: In the U.S., no major data was released, as several reports that usually come out on Thursdays or Fridays were accelerated into Wednesday due to the holiday. In China, shares of brokerages sold off sharply, with Citic Securities, Founder Securities and China Merchants all falling about 10% on news that the China Securities Regulatory Commission had launched investigations into the firms in an effort to limit short selling and speculation. Amid the rout in the brokerages, the Shanghai Composite index tumbled 5.5%. COMPANY NEWS: Shares of Disney (DIS) fell $3.56, or 3.0%, to $115.11 after the media giant disclosed in a regulatory filing late Wednesday that domestic subscribers for ESPN were estimated to have declined by 3M. As of October 3, ESPN had 92M subscribers in the U.S., as estimated by Nielsen Media Research. In the company's 10-K filing last year, Disney stated that Nielsen estimated that ESPN had 95M subscribers as of September 27, 2014. Disney's weakness weighed on its big media peers as well, with Twenty-First Century Fox (FOX, FOXA) falling 1.2%, Time Warner (TWX) dropping 0.74% and Viacom (VIA, VIAB) sliding 1.8%... Amazon (AMZN) shares were flattish, falling 0.3% despite Adobe Systems estimating that online shoppers in the U.S. would spend $1.7B in online shopping by the end of the day on Thanksgiving, a 22% jump from last year. Additionally, ChannelAdvisor estimated that Amazon had a "strong showing" on Thanksgiving day, calculating that its same-store sales grew 28.9% compared to last year. MAJOR MOVERS: Among the notable gainers was Exact Sciences (EXAS), which rose 3.8% to $9.23 after the Centers for Medicare and Medicaid Services, or CMS, posted the 2016 Clinical Diagnostic Laboratory Fee Schedule. Exact Sciences announced this morning that it has requested that CMS clarify the 2016 reimbursement rate for the company's Cologuard test. Also higher were shares of KaloBios Pharmaceuticals (KBIO), which jumped 30.8% to $34.83 after its new CEO, Martin Shkreli, announced last night via his Twitter account that after speaking with his counsel and advisers that he has decided to stop lending his KaloBios shares out until he "better [understands] the advantages of doing so." Among the noteworthy losers were a number of oil and gas explorers, as Pioneer Energy Services (PES), Stone Energy (SGY) and Southwestern Energy (SWN) fell 8%, 10.2% and 7.2%, respectively, during another down day for oil prices. INDEXES: The Dow fell 14.90, or 0.08%, to 17,798.49, the Nasdaq gained 11.38, or 0.2%, to 5,127.52, and the S&P 500 added 1.24, or 0.06%, to 2,090.11.
09:27 EDTEXASExact Sciences requests CMS clarify 2016 reimbursement rate for Cologuard
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November 20, 2015
07:02 EDTSPPISpectrum submits IND to FDA to initiate Phase 2 breast cancer study
Spectrum Pharmaceuticals announced today the company has submitted an IND application to the U.S. Food and Drug Administration and plans to initiate a Phase 2 breast cancer study in the U.S. as soon as possible. The Phase 2 study is planned to be an open-label study that will enroll approximately 70 patients with HER-2 positive metastatic breast cancer, who have failed at least one or more HER-2 directed therapy. The dose and schedule of oral poziotinib will be based on clinical experience from the studies in Korea, and in addition include the use of prophylactic therapies to help minimize known side-effects of HER2-directed therapies.
November 19, 2015
07:32 EDTEXASCanaccord to hold a forum
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07:07 EDTZIOPZIOPHARM announces data highlighting Ad-RTS-hIL-12 activity in Glioma
ZIOPHARM Oncology announced that the company is presenting initial results from an ongoing Phase 1 dose-escalation study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma or grade III malignant glioma. The presentation, titled "Intratumoral Regulated Expression of IL-12 as a Gene Therapy Approach to Treatment of Glioma," will be delivered at 5:15 pm CT, Saturday, November 21, 2015 at the 20th Annual Society for Neuro-Oncology, or SNO, Annual Scientific Meeting in San Antonio, Texas. Ad-RTS-hIL-12 + the oral activator veledimex is a novel viral gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T-cell immune response. The ongoing multi-center Phase 1 trial of Ad-RTS-hIL-12 + veledimex examines a gene therapy strategy for recurrent high grade gliomas, with the goal of generating a localized anti-tumor immune response. The primary objective of the study is to determine the safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12 injection activated upon dosing with oral veledimex. Secondary objectives are to determine the Ad-RTS-hIL-12 + veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 + veledimex, and assessment of biologic response. The study is expected to enroll up to 72 subjects. Preclinically, the effects of Ad-RTS-mIL-12 + veledimex were studied in orthotopic glioma animal models, demonstrating veledimex crossed the blood-brain-barrier. In a standard orthotopic glioma mouse model that evaluated dexamethasone, bevacizumab, temozolamide and a PD-1 inhibitor, Ad-RTS-mIL-12 + veledimex demonstrated a dramatic dose-related increase in survival, without significant adverse events, that was superior to all other treatments. In the current, on-going Phase 1 study, five patients are available for initial assessment, two with recurrent grade III malignant glioma and three with grade IV. Results show IL-12 was detectable in peripheral blood along with downstream IFNg, indicating that veledimex crossed the blood brain barrier activating IL-12 expression from intra-tumorally administered Ad-RTS-hIL-12. Ad-RTS-hIL-12 + veledimex was well tolerated with minimal neurologic toxicity. The most common adverse events were headache, fever, hyponatremia and nausea/vomiting. Related serious adverse events were aseptic meningitis, neutropenia, thrombocytopenia, leukopenia, with all toxicity to date consistent with the "on-target" effects of immunotherapy.
November 18, 2015
05:35 EDTSPPISpectrum divests rights to Zevalin in Japan, other countries
Spectrum Pharmaceuticals announced the divestment of Zevalin rights in Japan and other countries in Asia Pacific, Middle East, Africa and Latin America, to Mundipharma. Spectrum will receive an up-front payment of $15M plus $5M in profits on initial Zevalin supply. Spectrum will continue to own Zevalin rights for U.S., Canada, and Europe.

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