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April 15, 2014
07:35 EDTNVS, ALNYAlnylam outlook not affected by Novartis decision, says JMP Securities
After Novartis (NVS) discontinued its RNAi drug discovery program, JMP Securities does not think the decision should affect the potential of Alnylam's (ALNY) pipeline. The firm believes that Novartis' inability to figure out RNAi technology - and not problems with RNAi as a whole - led to Nvoartis' decision. The firm reiterates a $110 price target and Outperform rating on Alnylam.
News For ALNY;NVS From The Last 14 Days
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October 7, 2015
07:23 EDTNVSEuropean Committee Treatment & Research in Multiple Sclerosis holds meeting
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October 6, 2015
13:32 EDTNVSBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
October 5, 2015
05:25 EDTNVSAlcon receives FDA approval for AcrySof IQ Aspheric IOL
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October 1, 2015
13:00 EDTALNYAlnylam recent weakness a buying opportunity, says Piper Jaffray
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11:06 EDTNVSXOMA price target raised to $1.50 from $1 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for XOMA (XOMA) to $1.50 after the company partnered a preclinical TGF-beta antibody with Novartis (NVS) for $37M upfront and up to $480M in milestones. The payment brings XOMA's pro forma cash to $88M, enabling the company to advance its endocrine antibody pipeline, including lead candidate XOMA 358 for hyperinsulinism disorders, Tenthoff tells investors in a research note. The analyst keeps a Neutral rating on the name. The stock is up 20c to 95c in early trading.
07:37 EDTNVSXOMA announces agreement for anti-TGFb program with Novartis
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07:01 EDTALNYGenzyme opts into ALN-AT3 Hemophilia Program
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September 30, 2015
17:04 EDTNVSNovartis says results of Phase 3 study of secukinumab met endpoints
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07:11 EDTALNYLeerink to hold a roundtable
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September 29, 2015
12:35 EDTNVSPerrigo shareholders pressure company to explore sale, Reuters says
Certain Perrigo (PRGO) shareholders have requested that company explore a sale, hoping for an alternative to Mylan's (MYL) approximately $25B hostile bid, Reuters reports, citing people familiar with the matter. The pressure represents a challenge to Perrigo's defense strategy, the report says. Some of the company's shareholders view Novartis (NVS), Sanofi (SNY), Procter & Gamble (PG), and Colgate-Palmolive (CL) as potential suitors, the report says. Reference Link
08:46 EDTNVSNoven reports final decisions in IPRs challenging Novartis' Exelon patch patents
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September 28, 2015
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.
12:22 EDTNVSArray says binimetinib-encorafenib combo shows differentiated tolerability
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11:14 EDTALNYAlnylam OLE data has positive read through to Phase 3 trial, says Piper Jaffray
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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.
07:58 EDTNVSNovartis to hold a conference call
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September 27, 2015
18:48 EDTNVSNovartis reports updated Phase 3 data on Tafinlar-Mekinist for melanoma
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16:16 EDTNVSNovartis reports Phase 3 reults on Afinitor for neuroendocrine tumors
Novartis announced results of a Phase 3 pivotal study showing Afinitor, or everolimus, tablets reduced the risk of progression by 52% versus placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. Additionally, the data show everolimus, a mammalian target of rapamycin inhibitor, extended median progression free survival by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm. Overall survival was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm, according to Novartis. Additional analyses are planned. Another secondary endpoint was best overall response rate. The study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo. Adverse events were consistent with the known safety profile of everolimus. The results of the RADIANT-4 study will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET, Novartis said.
September 25, 2015
07:22 EDTNVSEuropean Society for Medical Oncology to hold a conference
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05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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