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Stock Market & Financial Investment News

News Breaks
April 14, 2014
14:42 EDTTKMR, NVS, ARWR, ALNYAlnylam slips after Novartis reportedly cuts back RNAi development
Shares of Alnylam (ALNY) are lower in afternoon trading after a biotech focused newsletter reported that its partner, pharmaceutical giant Novartis (NVS), confirmed plans to "significantly reduce" its ribonucleic acid interface, or RNAi, research efforts. WHAT'S NEW: FierceBiotech reported earlier today that Novartis has decided to significantly cut back its once-ambitious RNAi research efforts, citing ongoing problems associated with delivering these therapies and the small number of relevant targets they could target. A total of 26 Novartis staffers were working full-time on the RNAi program full time, which grew out of a partnership with Alnylam, the report noted. OTHERS TO WATCH: Tekmira Pharmaceuticals (TKMR), like Alnylam, is focused on advancing ribonucleic acid interference therapeutics. Arrowhead Research (ARWR) is another biopharmaceutical company developing RNAi therapeutics. PRICE ACTION: In afternoon trading, Alnylam shares are down 4.5% to $52.58, Tekmira's stock is down nearly 16% to $15.49, and Arrowhead shares are off 3% to $12.71. Shares of Novartis are up about 1% to $83.48.
News For ALNY;NVS;TKMR;ARWR From The Last 14 Days
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November 19, 2014
07:52 EDTALNYInforma Business Information to hold a conference
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06:11 EDTTKMRTekmira to host analyst day
Analyst Day to be held in New York on November 21 at 9 am. Webcast Link
November 18, 2014
07:32 EDTARWRArrowhead files for regulatory permission to begin Phase I ARC-AAT trial
Arrowhead Research recently filed an application for approval to begin a Phase 1 clinical trial of its RNAi-based therapeutic candidate, ARC-AAT, for the treatment of liver disease associated with alpha-1 antitrypsin deficiency. Pending approval, Arrowhead intends to proceed with a double blind, placebo-controlled dose escalation, Phase 1 study to determine the safety, tolerability, pharmacokinetics and effect on circulating alpha-1 antitrypsin levels of ARC-AAT in healthy volunteers and patients with alpha-1 antitrypsin deficiency. The study is planned to start in Australia in healthy volunteers and will dose escalate until predetermined levels of alpha-1 antitrypsin reduction are reached. Once these levels of protein knockdown are achieved, the study will transition into a population of patients with ZZ genotype alpha-1 antitrypsin deficiency to further evaluate escalating doses of ARC-AAT. The study is designed to enroll up to 48 subjects, including healthy volunteers and alpha-1 antitrypsin deficiency patients. The application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration.
November 17, 2014
17:03 EDTALNYAlnylam presents new pre-clinical data on RNAi therapeutic programs
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16:52 EDTNVSNovartis' LCZ696 could change course of heart failure for patients, study shows
New data on Novartis' investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction shows it has the potential to change the course of the disease for patients. In August, Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. The new analyses being presented for the first time at the American Heart Association Scientific Sessions 2014, with a paper being simultaneously published in Circulation, show that versus enalapril, LCZ696 significantly: reduced the risk of dying suddenly by 20% in HFrEF patients 45% of CV deaths and 36% of all cause deaths are sudden; reduced first and subsequent HFrEF hospitalizations by 21% and 23% respectively; reduced hospitalizations for a cardiovascular reason or for any reason both by 16%; reduced the need for more intense treatment at home by 16%; reduced emergency room visits because of rapid symptom worsening by 30%.
11:06 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
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08:44 EDTTKMRNebraska Medical announces death of third Ebola patient
The Nebraska Medical Center said via Twitter, "We are sorry to announce that the 3rd Ebola patient, Dr. Martin Salia, has passed away as a result of the advanced symptoms of the disease." Drug companies that are working on experimental Ebola vaccines or treatments include Peregrine (PPHM), Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX) and NewLink Genetics (NLNK). Some companies that offer protective clothing and waste disposal include Lakeland Industries (LAKE), Alpha Pro Tech (APT) and Sharps Compliance (SMED).
08:12 EDTTKMRDicerna announces license agreement with Tekmira for PH1 program
Dicerna Pharmaceuticals (DRNA) announced a licensing agreement for Dicerna to use Tekmira’s (TKMR) proprietary lipid nanoparticle technology for delivery of DCR-PH1, Dicerna’s investigational product candidate for primary hyperoxaluria type 1, a rare, inherited liver disorder that often results in kidney failure, and for which there are no approved therapies. This announcement follows the successful testing of DCR-PH1 in combination with Tekmira's LNP technology in animal models, including mice and non-human primates. Under the agreement, Dicerna will pay Tekmira $2.5 million upfront, as well as $22 million in potential development milestones, and a mid-single-digit royalty on future PH1 sales. Tekmira’s LNP system has shown in other human clinical studies to provide potent, safe and effective RNA delivery to hepatocytes. Licensing Tekmira’s LNP will streamline the development path for DCR-PH1 and allows Dicerna to focus its LNP efforts on its oncology pipeline.
07:09 EDTALNYAmerican Heart Association to hold a conference
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November 16, 2014
15:07 EDTNVSNovartis says arthritis drug secukinumab met primary endpoint
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November 14, 2014
14:53 EDTNVSCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies 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). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTNVSAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
06:31 EDTALNYAlnylam to host conference call
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06:04 EDTALNYAlnylam announces positive initial phase 2 data with Revusiran
Alnylam announced positive initial Phase 2 data with revusiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR cardiac amyloidosis. In the pilot Phase 2 study, revusiran was found to be generally well tolerated in TTR cardiac amyloidosis patients. Revusiran demonstrated clinical activity with an up to 98.2% knockdown of serum TTR – the disease causing protein. This included similar knockdown effects toward wild type and mutant TTR protein within V122I patients, who represent the most common genotype associated with inherited forms of TTR cardiac amyloidosis. In the five week course of treatment, there were no significant changes observed in a number of exploratory clinical measurements. Revusiran utilizes Alnylam’s proprietary GalNAc-conjugate delivery platform that enables subcutaneous delivery of RNAi therapeutics with a wide therapeutic index. The primary objective of the study was to evaluate the safety and tolerability of revusiran. The secondary objectives were to assess the clinical activity of revusiran toward serum levels of TTR and characterize the drug’s pharmacokinetic profile. In addition, a number of exploratory clinical measurements were performed at baseline and days 42 and 90 after start of dosing.
November 13, 2014
13:32 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
November 12, 2014
11:17 EDTNVSLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:18 EDTNVSUBS to hold a conference
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07:58 EDTNVSGenVec expects 2014 cash burn between $6M-$7M from Novartis collaboration
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