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June 10, 2014
07:56 EDTIDIX, MRK, GILDGilead weakness creates buying opportunity, says RBC Capital
After Gilead's (GILD) stock fell following Merck's (MRK) acquisition of Idenix (IDIX), RBC Capital expects Sovaldi sales to come in well above consensus estimates for 2015, potentially enabling Gilead's EPS to reach $8-$10. RBC Capital says that the market expects the sales of HCV treatments to drop significantly in 2016, but the firm does not agree with this outlook. RBC Capital keeps an Outperform rating on Gilead.
News For GILD;MRK;IDIX From The Last 14 Days
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November 23, 2015
09:39 EDTGILDActive equity options trading on open
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06:41 EDTGILDGilead granted marketing authorization in EU for Genvoya
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November 22, 2015
15:03 EDTMRKMerck reports multiple data sets from Keytruda combination studies
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November 19, 2015
06:34 EDTMRKEli Lilly, Merck expand immuno-oncology collaboration
Eli Lilly (LLY) and Merck (MRK) announced the extension of an existing collaboration to evaluate the safety and efficacy of the combination of Lilly's Alimta and Merck's Keytruda in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer, or NSCLC. The study will be sponsored by Merck and will be open to patients with NSCLC in the first-line setting, regardless of PD-L1 status. Financial details of the collaboration were not disclosed. The expansion of this oncology clinical trial collaboration comes following the release of encouraging data from a Phase I study, presented earlier this year at the 16th World Congress on Lung Cancer, which evaluated pemetrexed, carboplatin and pembrolizumab in first-line nonsquamous NSCLC.
November 18, 2015
09:34 EDTGILDActive equity options trading on open
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08:11 EDTMRKIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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07:01 EDTMRKThreshold enters into definitive co-promotion agreement with Merck
Threshold Pharmaceuticals (THLD) announced that it finalized a definitive Co-Promotion Agreement for evofosfamide with Merck (MRK) pursuant to the companies' License and Co-Development Agreement entered into on February 2, 2012. Under the terms of the License and Co-Development Agreement, Threshold may co-promote evofosfamide in the U.S. subject to FDA approval of evofosfamide. Evofosfamide is Threshold's investigational hypoxia-activated prodrug, which is currently the subject of two fully enrolled Phase 3 clinical trials in advanced soft tissue sarcoma and advanced pancreatic cancer for which Threshold expects to announce top-line data around the end of 2015. Under the commercial leadership of Merck KGaA, Darmstadt, Germany, the terms of the License and Co-Development Agreement give Threshold the right, at its own cost, to field and be responsible for its own sales force in collaboration with Merck KGaA, Darmstadt, Germany's sales force in the U.S. pursuant to the terms of the new Co-promotion Agreement. Merck KGaA, Darmstadt, Germany remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide. The development milestone payment and royalty payment portions of the License and Co-Commercialization Agreement remain the same. To date Threshold has received upfront and milestone payments of $110 million and can earn additional potential milestone payments of up to $440M.
November 17, 2015
10:47 EDTGILDBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
08:04 EDTMRKMerck to present new KEYTRUDA findings at upcoming congresses
Merck announced that data investigating the use of KEYTRUDA, the company's anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year. In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research 2015 Congress in San Francisco, Nov. 18 - 21; the 57th American Society of Hematology Annual Meeting in Orlando, Florida, Dec. 5 - 8; the San Antonio Breast Cancer Symposium, Dec. 8 - 12; and the European Society for Medical Oncology Asia 2015 Congress in Singapore, Dec. 18 - 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types. "The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."
November 16, 2015
09:04 EDTGILDGilead says Phase 3 Zydelig study shows 'clinical benefit'
Gilead announced that its Phase 3 Study 115 evaluating Zydelig added to standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology in Orlando, Florida taking place December 5-8. "The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."
08:35 EDTMRKMerck to present Phase 2 hep C therapy data at The Liver Meeting
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07:24 EDTMRKSalomon to hold a conference
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November 15, 2015
20:17 EDTGILDGilead presents results from four Phase 3 studies of sofosbuvir/velpatasvir
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15:47 EDTGILDGilead reports data from multiple studies of Viread, TAF, others
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15:19 EDTMRKMerck reports integrated analysis of six trials of elbasvir/grazoprevir
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15:15 EDTMRKMerck reports Phase 3 data on elbasvir/grazoprevir in patients injecting drugs
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November 13, 2015
08:02 EDTMRKMerck: DMC recommends anacetrapib study continue with no changes
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November 12, 2015
17:55 EDTGILDGilead announces FDA approval of Harvoni
Gilead Sciences announced that the U.S. FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
17:02 EDTMRKMerck Animal Health to Acquire Harrisvaccines
Merck Animal Health and Harrisvaccines announced the companies have entered into an agreement under which Merck Animal Health will acquire Harrisvaccines, a privately-held company that develops, manufactures and sells vaccines for food production and companion animals. The terms of the agreement were not disclosed. The companies expect the transaction to close in the fourth quarter of 2015.
11:50 EDTMRKMerck issues statement regarding CUBICIN patent litigation
Merck issued the following statement regarding the decision of the U.S. Court of Appeals for the Federal Circuit: "The decision validated the patent for CUBICIN that expires on June 15, 2016, but invalidated four patents with expiration dates in 2019 and 2020. The company is reviewing the decision and is considering its next steps, which may include seeking further review at the Federal Circuit or Supreme Court."
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