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News Breaks
August 25, 2014
05:17 EDTMRK, ADXSAdvaxis, Merck enter clinical trial collaboration agreement
Advaxis (ADXS) has entered into a clinical trial collaboration agreement with Merck (MRK), through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody, pembrolizumab. The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer. Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer treatments known as immunotherapies that are designed to enhance the body's own defenses in fighting cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response.
News For ADXS;MRK From The Last 14 Days
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January 29, 2015
09:07 EDTMRKHead researchers of Vertex, Regeneron, Merck invited to White House, CNBC says
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January 28, 2015
07:33 EDTADXSAdvaxis Phase 2 study achieves safety, efficacy criteria
Advaxis announced an update related to the Phase 2 open-label clinical study of ADXS-HPV in patients with persistent or recurrent cervical cancer with documented disease progression being conducted by the Gynecologic Oncology Group, or GOG, now part of NRG Oncology. The study, known as GOG 0265, has completed its first stage and has met the predetermined safety and efficacy criteria required to proceed into the second stage of patient enrollment. This trial is being conducted in the U.S. by the GOG, under the sponsorship of the Cancer Therapy Evaluation Program, or CTEP, of the National Cancer Institute, or NCI. GOG 0265 is an open-label, single arm 2-stage study designed to evaluate the safety, tolerability and efficacy of ADXS-HPV in approximately 67 patients. Patients receive one cycle of ADXS-HPV at 1 x 109 cfu every 28 days. The primary efficacy endpoint is 12-month survival, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects. Stage 1 enrolled 29 patients and stage 2 is set to enroll another 38. Further information about GOG 0265 can be found on ClinicalTrials.gov, using Identifier NCT01266460.
January 27, 2015
10:01 EDTADXSAdvaxis strength due to more than stock promotion, TheStreet says
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January 26, 2015
08:31 EDTMRKMerck says CHMP issues positive opinion for Sivextro
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO for the treatment of acute bacterial skin and skin structure infections in adults. Merck acquired SIVEXTRO as a part of its purchase, through a subsidiary, of Cubist Pharmaceuticals, Inc. The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. SIVEXTRO is a once-daily oxazolidinone antibiotic developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria.
January 23, 2015
06:39 EDTMRKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 22, 2015
11:04 EDTADXSAdvaxis announces FDA acceptance of IND application to conduct Phase 1 trial
Advaxis (ADXS) announced that the U.S. FDA has cleared its Investigational New Drug application to conduct a Phase 1 clinical study of ADXS-HER2 for the treatment of patients with metastatic HER2 expressing solid tumors. The clinical trial, which will be the first-in-human study of Advaxis's lead Lm-LLO immunotherapy product for HER2 expressing cancers, is expected to begin patient enrollment in the first half of 2015. In May 2014, Advaxis was granted orphan drug designation by the FDA for ADXS-HER2 in osteosarcoma.The Phase 1 clinical study is designed to evaluate the safety and tolerability of ADXS-HER2 as a monotherapy in patients with metastatic HER2 expressing solid tumors such as breast, gastric, esophageal, and osteosarcoma. Results from the study will be used to determine the future clinical development program of ADXS-HER2. The safety and efficacy of ADXS-HER2 is currently being evaluated in an ongoing Phase 1/2 veterinary clinical study in pet dogs with osteosarcoma, conducted by Nicola Mason, BVet.Med, Ph.D., DACVIM, of the University of Pennsylvania School of Veterinary Medicine. To date, dogs treated with ADXS-HER2 immunotherapy, after receiving standard of care had a statistically significant overall survival benefit compared to dogs that only received standard of care. Additionally, the preliminary data suggests immune responses induced by ADXS-HER2 targeted pulmonary micrometastases and prevent the development of metastatic disease in the dog's lungs.Advaxis has granted exclusive worldwide rights to Aratana Therapeutics (PETX) to develop and commercialize ADXS-HER2 for the treatment of osteosarcoma in dogs. In July 2014, Aratana filed a U.S. Department of Agriculture product license application for ADXS-HER2 for the treatment of canine osteosarcoma and other cancers. While the USDA has no specific obligation to respond within a prescribed timeframe, the companies expect a response within 12 to 18 months from the date the application was filed.
January 21, 2015
10:26 EDTADXSHigh option volume stocks
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10:16 EDTMRKLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
09:32 EDTADXSAdvaxis mentioned cautiously by Seeking Alpha contributor
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08:02 EDTMRKMerck completes tender offer to acquire Cubist
Merck (MRK) announced the successful completion of the tender offer for all of the outstanding shares of common stock of Cubist Pharmaceuticals (CBST) at a purchase price of $102.00 per share. As of the tender offer expiration yesterday, 58,039,667 shares of common stock of Cubist were validly tendered and not properly withdrawn from the tender offer, representing approximately 75.7% of the outstanding common stock of Cubist on a fully diluted basis. All of such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for all such shares. Following consummation of the tender offer, Merck expects to complete the acquisition of Cubist later today through a merger of Merckís wholly owned subsidiary with and into Cubist without stockholder approval. Upon completion of the merger, all outstanding shares of common stock of Cubist, other than shares held by Cubist in treasury or shares held by Cubistís stockholders who are entitled to and properly exercise appraisal rights under Delaware law, will be canceled and converted into the right to receive cash equal to the $102.00 offer price per share without interest, less any applicable withholding taxes. In addition, upon completion of the merger, Cubist will become a wholly owned subsidiary of Merck and the common stock of Cubist will cease to be traded on the NASDAQ Stock Market.
January 20, 2015
17:18 EDTMRKDana Holding to replace Cubist in S&P 400 as of 1/22 close
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10:06 EDTADXSHigh option volume stocks
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07:23 EDTMRKMerck funding testing of lower dosages of Zilmax, Reuters reports
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January 15, 2015
11:20 EDTMRKGoldman cuts J&J to sell citing competitive pressures
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07:59 EDTMRKAmerican Society of Clinical Oncology to hold a symposium
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