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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Celldex jumps on interim Phase II glioblastoma data

    Celldex Therapeutics Inc. (NASDAQ:CLDX) was up $4.09 (29%) to $18.25 on Monday after it said rindopepimut (CDX-110) increased progression-free survival at 6 months, the primary endpoint, and showed an overall survival …

    Published on 11/17/2014
  • CLINICAL NEWS: Vytorin meets CV endpoints in IMPROVE-IT trial

    Vytorin ezetimibe/simvastatin from Merck & Co. Inc. (NYSE:MRK) met the primary and all secondary composite endpoints versus Zocor simvastatin alone in the intent-to-treat population of the Phase III IMPROVE-IT trial …

    Published on 11/17/2014
  • CLINICAL NEWS: Alnylam planning revusiran Phase III

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said results from a Phase II study of its RNAi therapeutic revusiran (ALN-TTRsc) to treat transthyretin (TTR) cardiac amyloidosis support advancement into Phase III. The …

    Published on 11/14/2014
  • CLINICAL NEWS: Puma falls after breast cancer miss

    Puma Biotechnology Inc. (NYSE:PBYI) lost $23.27 (10%) to $216.22 on Friday after its neratinib (HKI-272, PB272) missed both the primary endpoint of improving progression-free survival (PFS) and the secondary endpoint of…

    Published on 11/14/2014
  • CLINICAL NEWS: VBL sees survival benefit in GBM Phase I/II

    VBL Therapeutics Ltd. (NASDAQ:VBLT) said preliminary data from a Phase I/II study of its VB-111 to treat recurrent glioblastoma multiforme (rGBM) suggest the gene-based dual anti-angiogenic and vascular disruptive agent…

    Published on 11/13/2014
  • CLINICAL NEWS: Ocular stays the course in allergic conjunctivitis

    Ocular Therapeutix Inc. (NASDAQ:OCUL) said it will continue to pursue development of OTX-DP to treat allergic conjunctivitis after the molecule met one of two primary endpoints in a Phase II trial.On one endpoint, …

    Published on 11/12/2014
  • CLINICAL NEWS: AbbVie reports HCV combo results

    AbbVie Inc. (NYSE:ABBV) and partner Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) reported new data from studies of a three direct-acting-antiviral (3-DAA) regimen of ABT-450 plus ombitasvir (ABT-267), dasabuvir (ABT-333) …

    Published on 11/11/2014
  • CLINICAL NEWS: No SAEs in dialysis study of Akebia's AKB-6548

    Akebia Therapeutics Inc. (NASDAQ:AKBA) jumped $1.37 (15%) to $10.36 on Tuesday after publication of an abstract showing that AKB-6548 led to no serious adverse events or treatment discontinuations in a Phase II …

    Published on 11/11/2014
  • CLINICAL NEWS: Regeneron, Sanofi plannning dupilumab Phase III in asthma

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said they plan to run a Phase III trial of dupilumab to treat adults with uncontrolled moderate-to-severe asthma after interim …

    Published on 11/11/2014
  • CLINICAL NEWS: Achillion hits 52-week high on HCV data

    Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) gained $2.74 (27%) to $12.85 on Monday after reporting an SVR12 of 100% in an ongoing Phase II study of ACH-3102 to treat HCV genotype 1 at the American Association for the …

    Published on 11/10/2014
  • CLINICAL NEWS: Merck reports HCV triple-combo results

    Merck & Co. Inc. (NYSE:MRK) presented results from a Phase II study of a triple combination including grazoprevir (MK-5172) and elbasvir (MK-8742; MK-5172A) showing an SVR4 and SVR8 rate of 94.7% among cirrhotic, …

    Published on 11/10/2014
  • CLINICAL NEWS: Sage's seizure treatment leads to 73% ORR

    Sage Therapeutics Inc. (NASDAQ:SAGE) said its SAGE-547 led to a 73% overall response rate in a Phase I/II trial to treat super-refractory status epilepticus (SRSE).The study enrolled 12 adults who had been in a state of…

    Published on 11/10/2014
  • CLINICAL NEWS: bluebird gains on interim LentiGlobin data

    bluebird bio Inc. (NASDAQ:BLUE) was up $2.69 to $41.70 after publication of abstracts of two studies of LentiGlobin BB305 gene therapy to treat beta thalassemia major via autologous hematopoietic stem cell …

    Published on 11/6/2014
  • CLINICAL NEWS: No new responders to Epizyme's Phase I leukemia therapy

    Epizyme Inc. (NASDAQ:EPZM) lost $2.90 (11%) to $23.70 on Thursday after publication of an abstract showing that no new patients added to a Phase I trial of EPZ-5676 to treat acute leukemia achieved complete responses. …

    Published on 11/6/2014
  • CLINICAL NEWS: Investors rebuff Celldex's METRICs

    Celldex Therapeutics Inc. (NASDAQ:CLDX) shed $3.48 (21%) to $13.10 on Wednesday on changes to the pivotal Phase II METRIC study of glembatumumab vedotin to treat metastatic triple-negative breast cancers (TNBC) that …

    Published on 11/5/2014
  • CLINICAL NEWS: Novartis and GenVec gene therapy enters Phase I/II

    Novartis AG (NYSE:NVS; SIX:NOVN) has dosed the first patient in a Phase I/II trial of CGF166 to treat severe hearing loss. The trial start triggers a $3 million milestone payment to GenVec Inc. (NASDAQ:GNVC), which …

    Published on 11/5/2014
  • CLINICAL NEWS: After PDUFA date passes, more data on Novo's liraglutide

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said 92% of obese, non-diabetic patients receiving 3 mg injections of liraglutide lost weight in the Phase III SCALE trial to treat obesity, compared with 65% of those on placebo. …

    Published on 11/4/2014
  • CLINICAL NEWS: Amgen's trebananib misses Phase III OS endpoint

    Amgen Inc. (NASDAQ:AMGN) reported that trebananib failed to improve overall survival among recurrent platinum-resistant ovarian cancer patients in the Phase III TRINOVA-1 study. The compound missed the top-line …

    Published on 11/4/2014
  • CLINICAL NEWS: Geron jumps on lift of imetelstat clinical hold

    Geron Corp. (NASDAQ:GERN) climbed $0.57 (26%) to $2.80 on Monday after FDA lifted a full clinical hold on company-sponsored trials of imetelstat (GRN163L), an oligonucleotide that competitively inhibits telomerase …

    Published on 11/3/2014
  • CLINICAL NEWS: BIND gains on Phase II NSCLC data

    Bind Therapeutics gained $1.11 (14%) to $8.94 after publication of an abstract containing preliminary data from a Phase II trial of BIND-014 to treat non-small cell lung cancer (NSCLC). The compound had a 63% disease …

    Published on 10/30/2014
  • CLINICAL NEWS: BMS jumps on Phase II data behind Opdivo BLA

    Bristol-Myers Squibb Co. (NYSE:BMY) added $4.82 (9%) to $58.98 Thursday when it reported a 15% objective response rate (ORR) and estimated a 41% one-year survival rate in the Phase II CheckMate -063 trial evaluating …

    Published on 10/30/2014
  • CLINICAL NEWS: NIH studying Kowa's statin in HIV

    The National Institutes of Health is starting a North American trial of pitavastatin from Kowa Co. Ltd. (Nagoya, Japan) to prevent cardiovascular disease in HIV patients. The double-blind, placebo-controlled 6,500-…

    Published on 10/28/2014
  • CLINICAL NEWS: Novavax climbs on vaccine data

    Novavax Inc. (NASDAQ:NVAX) gained $0.67 (13%) to $5.80 after presenting data from two vaccine trials for Ebola virus and respiratory syncytial virus (RSV) at the Vaccine & ISV Congress in Philadelphia.The company …

    Published on 10/27/2014
  • CLINICAL NEWS: One-year follow up for uniQure's liver gene therapy

    uniQure N.V. (NASDAQ:QURE) reported top-line one-year follow-up data from a completed Phase I study in eight acute intermittent porphyria (AIP) patients receiving varying doses of the company's AMT-021, a recombinant …

    Published on 10/27/2014
  • CLINICAL NEWS: Novartis' secukinumab meets in ankylosing spondylitis

    Three days after an FDA committee backed the approval of Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) for moderate to severe plaque psoriasis, the compound met its primary and key secondary endpoints in …

    Published on 10/23/2014

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