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March 26, 2014
08:06 EDTSNY, ALNY, MRKGenzyme exercises right to purchase additional shares of Alnylam common stock
Alnylam (ALNY) announced that Genzyme, a Sanofi (SNY) company, has exercised its right to purchase 344,448 unregistered shares of Alnylamís common stock in accordance with the terms of an investor rights agreement between Alnylam and Genzyme, dated January 11. These shares became available for purchase by Genzyme as a result of Alnylamís issuance of shares of common stock to Merck (MRK) in connection with Alnylamís acquisition of Sirna Therapeutics. Under the investor rights agreement, Genzyme has the right to purchase additional shares to maintain its ownership percentage of the companyís common stock. On March 25, Genzyme purchased these additional shares at a purchase price of $66.88, the closing price of Alnylamís stock that day, and paid the company approximately $23M. The exercise of this right to purchase the maximum number of additional shares under the terms of the investor rights agreement allows Genzyme to maintain its current ownership level of Alnylam common stock of approximately 12%.
News For ALNY;SNY;MRK From The Last 14 Days
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September 29, 2015
08:07 EDTSNYSanofi announces FDA accepted filing of NDA for lixisenatide
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05:16 EDTSNYSanofi announces NDA for Lixisenatide accepted for review by FDA
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September 28, 2015
15:18 EDTMRKMerck volatility at 52-week high
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14:49 EDTALNYAlnylam granted summary judgment by U.S. district court in patent dispute
Alnylam Pharmaceuticals announced that Chief Judge Patti Saris of the U.S. District Court for the District of Massachusetts granted Alnylam's summary judgment motion in an inventorship dispute, holding that Professor Brenda Bass, Distinguished Professor at the University of Utah, is not a co-inventor of certain patents, termed the Tuschl II patents, jointly owned by co-defendants the Max Planck Society, UMass, Massachusetts Institute of Technology, and the Whitehead Institute for Biomedical Research, and exclusively licensed to Alnylam. In 2011 Utah sued Alnylam, Max Planck, UMass, MIT, and Whitehead alleging that Dr. Bass was either the sole or a co-inventor of the Tuschl II patents, seeking correction of inventorship as well as unspecified monetary damages. In 2015 Utah dropped their sole inventorship claim. The Court found that there was no collaboration between Dr. Bass and Dr. Tuschl, which is a pre-requisite for co-inventorship, and also granted the defendants' motion for summary judgment on Utah's state law claims. While Utah can appeal this ruling, Alnylam remains firm in its belief that the inventorship of the Tuschl II patents as stated in the issued patents is correct, the company said.
11:14 EDTALNYAlnylam OLE data has positive read through to Phase 3 trial, says Piper Jaffray
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09:35 EDTSNYEli Lilly and Sanofi reach settlement agreement in glargine litigation
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09:33 EDTSNYSanofi reaches patent settlement with Eli Lilly on Lantus
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08:05 EDTALNYAlnylam reports new results from ongoing Phase 2 OLE study of patisiran
Alnylam Pharmaceuticals and collaborators announced new results from the company's ongoing Phase 2 open-label extension study of patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis patients with familial amyloidotic polyneuropathy. In collaboration with investigators at The Scripps Research Institute and Misfolding Diagnostics, Inc., patisiran administration was shown to reduce pathogenic, misfolded TTR monomers and oligomers in FAP patients in the Phase 2 OLE study. Specifically, patisiran administration resulted in a rapid and sustained reduction of approximately 90% in serum non-native conformations of TTR. Since NNTTR is pathogenic in ATTR amyloidosis, these results provide direct mechanistic evidence supporting the therapeutic hypothesis that TTR knockdown has the potential to result in clinical benefit. In addition, Alnylam presented complete 12-month data from all 27 patients initially enrolled in the patisiran OLE study, showing a mean 3.1-point decrease in the modified Neuropathy Impairment Score at 12 months as well as sustained mean maximum reductions in total serum TTR of 91% for over 18 months. Moreover, patisiran administration was found to be generally well tolerated out to 21 months of treatment. Alnylam's ongoing Phase 2 OLE study is an open-label, multi-center trial designed to evaluate the long-term safety and tolerability of patisiran administration in FAP patients that were previously enrolled in a Phase 2 study. Patisiran is being administered once every 3 weeks at a dose of 0.3 mg/kg by intravenous infusion. The study is measuring a number of clinical endpoints every six months, including mNIS+7 which is an evaluation of muscle weakness, sensory and autonomic function, and nerve conductance, where neuropathy progression leads to an increased score over time. The change in the mNIS+7 measurement from baseline to 18 months is the primary endpoint in the company's ongoing Phase 3 APOLLO trial of patisiran in FAP patients.
08:02 EDTMRKSyndax and Merck announce patients dosed in trial of Entinostat and Keytruda
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07:52 EDTSNY, MRKIIR Holdings to hold a conference
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07:31 EDTMRKMerck says Japan's PMDA approves Marizev DPP-4 inhibitor for Type 2 diabetes
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05:18 EDTSNYRegeneron and Sanofi announce of approval of Praluent in EU
Regeneron (REGN) and Sanofi (SNY) announced that the European Commission has granted marketing authorization for Praluent for the treatment of bad cholesterol, known as low-density lipoprotein cholesterol, in certain adult patients with hypercholesterolemia. Praluent is the only EC-approved PCSK9 inhibitor that is available in two starting doses as a single 1-milliter injection once every two weeks, offering two levels of efficacy. Praluent will be available in a single-dose pre-filled pen that patients self-administer. The EC approved Praluent for the treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
September 27, 2015
16:47 EDTMRKMerck reports Phase 1b data on Keytruda for two gastrointestinal cancers
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14:58 EDTMRKMerck announces Phase 1b data on Keytruda for nasopharyngeal cancer
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September 25, 2015
15:31 EDTMRKMerck volatility elevated as shares trend lower
Merck October weekly call option implied volatility is at 39, October is at 34, November is a 29; compared to its 52-week range of 15 to 34, suggesting large price movement after presidential candidate Hilary Clinton announced plans early this week to cap prescription drug prices.
08:15 EDTMRKMerck narrow Keytruda label may not matter as much as thought, says Bernstein
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07:22 EDTSNYEuropean Society for Medical Oncology to hold a conference
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September 24, 2015
17:04 EDTMRKMerck, Pfizer to collaborate with Agilent's Dako on Avelumab diagnostic
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16:03 EDTMRKNewLink Genetics awarded $8.1M from DTRA to advance Ebola vaccine
NewLink Genetics (NLNK) announced that the Defense Threat Reduction Agency of the Department of Defense has awarded a subsidiary of NewLink Genetics an $8.1M base contract with future options totaling $5.2M to support various development activities of the investigational rVSV-ZEBOV Ebola) vaccine candidate. NewLink has exclusively licensed research, development and manufacturing of the rVSV-ZEBOV vaccine to Merck (MRK). In late 2014, Merck, known as MSD outside the United States and Canada, licensed the vaccine from NewLink Genetics to apply Merck's vaccine expertise to help accelerate the development of this vaccine candidate. Clinical studies of the rVSV-ZEBOV are ongoing.
September 23, 2015
08:50 EDTMRKProvectus initiates Phase 1b/2 trial of PV-10 combo with Pembrolizumab
Provectus Biopharmaceuticals (PVCT) announced it has completed development of the protocol for Phase1b/2 testing of its investigational cancer drug PV-10 in combination with pembrolizumab in patients with Stage IV melanoma. Pembrolizumab, also known as Keytruda, a product of Merck (MRK), is an immune checkpoint inhibitor approved for treatment of patients with advanced or unresectable melanoma. PV-10 is Provectus's novel investigational drug for cancer that is injected into solid tumors. It is currently undergoing Phase 3 clinical testing in patients with Stage III melanoma. Clinical testing under the new Phase 1b/2 protocol is expected to commence before the end of the year. The FDA granted accelerated approval to pembrolizumab in September 2014, making it the first FDA-approved anti-PD-1 immune checkpoint inhibitor. Because pembrolizumab is already FDA-approved, Provectus can commence this study with or without assistance of a partner.
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