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Chronological Index of : Clinical News

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  • CLINICAL NEWS: New data show survival benefit of Biogen's Spinraza

    Newly released data showed that Spinraza nusinersen from Biogen Inc. (NASDAQ:BIIB) met a second primary endpoint of the Phase III ENDEAR study to treat spinal muscular atrophy. The therapy significantly reduced risk of …

    Published on 1/13/2017
  • CLINICAL NEWS: Shionogi's cefiderocol passes Phase II cUTI test

    Shionogi & Co. Ltd. (Tokyo:4507) said cefiderocol (S-649266) met FDA's pre-specified primary endpoint of the Phase II APEKs-cUTI study to treat complicated urinary tract infection with Gram-negative bacteria. The …

    Published on 1/12/2017
  • CLINICAL NEWS: CureVac's prostate cancer vaccine fails in Phase IIb trial

    CureVac AG (Tuebingen, Germany) said its lead vaccine candidate CV9104 failed to improve overall survival in a Phase IIb study to treat castration-resistant prostate cancer (CRPC), missing its primary endpoint. The …

    Published on 1/11/2017
  • CLINICAL NEWS: Debiopharm antibiotic passes Phase II ABSSSI test

    Debiopharm Group (Lausanne, Switzerland) said antibiotic candidate Debio 1450 met the primary endpoint of non-inferiority to vancomycin plus linezolid across all tested Staphylococcus species in a Phase II trial to …

    Published on 1/10/2017
  • CLINICAL NEWS: Moderna lifts veil on pipeline

    At a presentation at the JPMorgan Healthcare Conference on Tuesday, mRNA vaccines and therapeutics company Moderna Therapeutics Inc. (Cambridge, Mass.) CEO Stephane Bancel outlined the company's pipeline as it prepares …

    Published on 1/10/2017
  • CLINICAL NEWS: Paper suggests Aravive compound could block Zika

    In a study published Tuesday in Cell Reports, researchers from INSERM and Aravive Biologics Inc. (Houston, Texas) said Aravive's preclinical candidate Aravive-S6 could protect glial cells from Zika infection.Aravive-S6 …

    Published on 1/10/2017
  • CLINICAL NEWS: BioMarin eyeing pivotal hemophilia gene therapy trial

    In updated results from its Phase I/II study of gene therapy BMN 270 to treat severe hemophilia A, BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said Monday that the seven patients treated with the study's highest dose …

    Published on 1/9/2017
  • CLINICAL NEWS: Incyte, Merck expand IDO1/PD-1 combo plans

    Incyte Corp. (NASDAQ:INCY) and Merck & Co. Inc. (NYSE:MRK) expanded their Phase III development plan for epacadostat (INCB024360) plus Keytruda pembrolizumab. This year, the companies plan to begin pivotal studies of …

    Published on 1/9/2017
  • CLINICAL NEWS: AACR releases Project GENIE data

    The American Association for Cancer Research (AACR) released a set of cancer genomic data through its Genomics Evidence Neoplasia Information Exchange (GENIE) initiative. The data set includes 19,000 de-identified …

    Published on 1/6/2017
  • CLINICAL NEWS: Halozyme rises after Phase II pancreatic cancer readout

    Halozyme Therapeutics Inc. (NASDAQ:HALO) gained $1.92 (18%) to $12.61 after it reported data from the Phase II HALO 202 study of PEGPH20 to treat pancreatic cancer. The candidate met both of the study's primary …

    Published on 1/5/2017
  • CLINICAL NEWS: Malaria vaccine shows promise in Phase Ia trial

    In a study published Wednesday in Science Translational Medicine, researchers at the Center for Infectious Disease Research and Fred Hutchinson Cancer Research Center said a vaccine using genetically attenuated …

    Published on 1/4/2017
  • CLINICAL NEWS: Inotek plummets on Phase III glaucoma miss

    Inotek Pharmaceuticals Corp. (NASDAQ:ITEK) sank $4.35 (71%) to $1.75 after it said trabodenoson (INO-8875) monotherapy missed the primary endpoint of the Phase III MATrX-1 trial to treat primary open-angle glaucoma or …

    Published on 1/3/2017
  • CLINICAL NEWS: Opko GHD candidate fails Phase III study in adults

    Opko Health Inc. (NASDAQ:OPK; Tel Aviv:OPK) on Friday reported its long-acting human growth hormone (hGH) analog hGH-CTP missed the primary endpoint in a Phase III trial to treat adults with growth hormone deficiency. …

    Published on 12/30/2016
  • CLINICAL NEWS: Seattle Genetics hit by clinical holds in AML

    Seattle Genetics Inc. (NASDAQ:SGEN) shed about $1.3 billion in market cap this week after FDA placed full and partial clinical holds on early stage trials of vadastuximab talirine (SGN-CD33A) to treat acute myelogenous …

    Published on 12/30/2016
  • CLINICAL NEWS: Synergy's plecanatide hits mark in second Phase III

    Synergy Pharmaceuticals Inc. (NASDAQ:SGPY) gained $1.03 (22%) to $5.77 on Friday following its after-hours announcement on Thursday that plecanatide (formerly SP-304) met the primary endpoint of a second Phase III trial…

    Published on 12/23/2016
  • CLINICAL NEWS: Merrimack halts Phase II breast cancer trial

    Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) sank $0.99 (18%) to $4.38 on Wednesday after stopping the Phase II HERMIONE trial of MM-302 to treat HER2-positive metastatic breast cancer. The company said it conducted a …

    Published on 12/21/2016
  • CLINICAL NEWS: Acadia rises on Nuplazid AD readout

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) gained $3.14 (12%) to $28.57 after it said Nuplazid pimavanserin met the primary endpoint of a Phase II exploratory study to treat Alzheimer's disease psychosis, but missed a …

    Published on 12/20/2016
  • CLINICAL NEWS: COMPASS points Ionis toward hypertriglyceridemia submissions

    Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said volanesorsen (IONIS-APOCIIIRx) met the primary endpoint in the Phase III COMPASS trial in patients with severe hypertriglyceridemia. Next year, the company plans to submit …

    Published on 12/19/2016
  • CLINICAL NEWS: Agios discontinues PKD candidate

    Agios Pharmaceuticals Inc. (NASDAQ:AGIO) fell $10.66 (19%) to $45.28 in early after hours trading after it said it discontinued development of AG-519 to treat pyruvate kinase deficiency after FDA placed a clinical hold …

    Published on 12/15/2016
  • CLINICAL NEWS: Centrexion's pain candidate passes Phase IIb test

    Centrexion Therapeutics Corp. (Boston, Mass.) said pain candidate CNTX-4975 met the primary endpoint in a Phase IIb study to treat osteoarthritis (OA) knee pain. Compared with placebo, each of two tested doses …

    Published on 12/13/2016
  • CLINICAL NEWS: Kyowa PD drug misses in global Phase III

    Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said istradefylline (KW-6002) missed the primary endpoint in a global Phase III trial to treat moderate to severe Parkinson's disease in patients with "wearing-off" phenomena on …

    Published on 12/13/2016
  • CLINICAL NEWS: Proteon crumbles after Phase III patency miss

    Proteon Therapeutics Inc. (NASDAQ:PRTO) plummeted $7.40 (75%) to $2.50 after it said vonapanitase (formerly PRT-201) missed the primary endpoint in the Phase III PATENCY-1 trial in patients with chronic kidney disease (…

    Published on 12/13/2016
  • CLINICAL NEWS: Achaogen antibiotic headed toward submissions

    Achaogen Inc. (NASDAQ:AKAO) rocketed $7.78 (148%) to $13.03 on Monday after reporting that its lead candidate plazomicin (ACHN-490) met FDA's and EMA's primary endpoints in the Phase III EPIC trial in patients with …

    Published on 12/12/2016
  • CLINICAL NEWS: Ophthotech craters after Phase III AMD failure

    Ophthotech Corp. (NASDAQ:OPHT) lost $33.48 (86%) to $5.29 on Monday after it said Fovista pegpleranib missed the primary endpoints in the Phase III OPH1002 and OPH1003 trials to treat wet age-related macular …

    Published on 12/12/2016
  • CLINICAL NEWS: Researchers identify CRISPR/Cas9 "off-switch"

    In a manuscript published in Cell, researchers identified three families of naturally-occurring protein inhibitors of CRISPR/Cas9 gene editing, which they said could be used for spatial, temporal or conditional control …

    Published on 12/12/2016

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