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News Breaks
June 1, 2014
14:05 EDTMRKMerck presents early findings from Phase 1b study for pembrolizumab
Merck announced the first presentation of early findings from a Phase 1b study evaluating pembrolizumab, MK-3475, Merck’s investigational anti-PD-1 antibody, as a single-agent, monotherapy, in patients with PD-L1 positive, advanced head and neck cancer. Early data showed a best overall response rate of 20% with 29% of patients having stable disease as measured by RECIST criteria . Similar overall response rates were observed in Human papillomavirus, HPV-positive and HPV-negative patients – HPV infection is a risk factor for some types of head and neck cancer. In the study, tumor shrinkage was demonstrated in 51% of evaluable patients who had measurable disease with one post baseline scan, per RECIST criteria. These early findings will be presented in an oral session by Dr. Tanguy Seiwert, associate director of the Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago, at the 50th Annual Meeting of the American Society of Clinical Oncology. “Recurrent and metastatic head and neck cancer carries a very poor prognosis, and often is accompanied by poor quality of life and disfigurement. Additional treatment options are urgently needed,” said Dr. Seiwert. “These early response data with pembrolizumab as monotherapy provide an encouraging proof of concept and support further study of this novel investigational immunotherapy in this hard-to-treat cancer type.” “We continue to observe robust signals of anti-tumor activity in response to pembrolizumab monotherapy across multiple tumor types and lines of therapy, including these data in head and neck cancer,” said Dr. Roy Baynes, senior vice president, global clinical development, Merck Research Laboratories. “The breadth of data to be presented at ASCO underscores why Merck is advancing a broad development program for pembrolizumab across more than 30 tumor types, including late-stage studies in head and neck and other cancers.”
News For MRK From The Last 14 Days
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May 27, 2015
05:49 EDTMRKStocks with implied volatility movement; MRK EFA
Stocks with implied volatility movement; Merck (MRK) 19, iShares MSCI EAFE Index Fund (EFA) 16 according to iVolatility.
May 26, 2015
16:01 EDTMRKOptions Update; May 26, 2015
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06:36 EDTMRKMerck announces Simponi received CHMP positive opinion
MSD, known as Merck & Co., in the U.S. and Canada, announced that SIMPONI has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein, or CRP, and/or magnetic resonance imaging evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Once the EU commission issues their EC decision, and if approved, nr-axial SpA patients can be considered for the once-monthly subcutaneous injection with SIMPONI.
May 22, 2015
10:52 EDTMRKJPMorgan says Actavis shares cheap compared to peers
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07:22 EDTMRKMerck receives positive CHMP opinion for Pembrolizumab in advanced melanoma
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07:15 EDTMRKMerck receives positive CHMP opinion for KEYTRUDA in advanced melanoma
Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for KEYTRUDA, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union.
May 19, 2015
07:28 EDTMRKUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
06:55 EDTMRKGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 14, 2015
09:22 EDTMRKLeerink pharma/biotech analysts hold an analyst/industry conference call
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May 13, 2015
18:33 EDTMRKMerck to present new Keytruda data on 10 types of cancer at 2015 ASCO meeting
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13:12 EDTMRKSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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