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Chronological Index of : Clinical News

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  • CLINICAL NEWS: BioCryst falls on HAE miss for avoralstat

    BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) crumbled $4.36 (71%) to $1.78 on Monday after its oral avoralstat (BCX4161) missed the primary endpoint in the Phase II/III OPuS-2 trial to prevent acute attacks in patients …

    Published on 2/8/2016
  • CLINICAL NEWS: CTI's pacritinib on partial clinical hold

    CTI BioPharma Corp. (NASDAQ:CTIC; Milan:CTIC) fell $0.68 (61%) to $0.44 on Monday after it said FDA placed a partial clinical hold on on pacritinib (BAX 2201), citing "excess mortality and other adverse events" in the …

    Published on 2/8/2016
  • CLINICAL NEWS: Amgen's Blincyto improves OS in ALL Phase III

    Amgen Inc. (NASDAQ:AMGN) said an interim analysis showed Blincyto blinatumomab met the primary overall survival (OS) endpoint vs. standard of care chemotherapy in the open-label Phase III TOWER trial to treat …

    Published on 2/5/2016
  • CLINICAL NEWS: Lilly's tadalafil fails DMD Phase III

    In an update provided to Parent Project Muscular Dystrophy, Eli Lilly and Co. (NYSE:LLY) said a Phase III trial of tadalafil (LY450109) to treat Duchenne muscular dystrophy (DMD) "provided no evidence that once-daily …

    Published on 2/4/2016
  • CLINICAL NEWS: Vanderbilt team finds new biomarker of anti-PD-1 sensitivity

    A Vanderbilt University research team has identified a biomarker for predicting sensitivity to anti-PD-1 therapies in melanoma patients. The authors suggested that the biomarker could be cheaper and easier to measure …

    Published on 2/3/2016
  • CLINICAL NEWS: Axovant falls on read-through concerns for AD program

    Axovant Sciences Ltd. (NYSE:AXON) lost $2.99 (18%) to $13.66 on Tuesday after Pfizer Inc. (NYSE:PFE) disclosed in a pipeline update that it discontinued development of a serotonin (5-HT6) receptor antagonist for …

    Published on 2/2/2016
  • CLINICAL NEWS: Synthetic slides after dropping Trimesta for RRMS

    Synthetic Biologics Inc. (NYSE-M:SYN) fell $0.21 (14%) to $1.28 on Tuesday after it said it terminated a license with the Regents of the University of California to IP covering the use of Trimesta, an oral estriol, as …

    Published on 2/2/2016
  • CLINICAL NEWS: Exelixis' cabozantinib shows OS benefit in RCC

    Exelixis Inc. (NASDAQ:EXEL) said cabozantinib (XL-184) showed an overall survival (OS) benefit over Afinitor everolimus from Novartis AG (NYSE:NVS; SIX:NOVN) in the Phase III METEOR trial to treat advanced or metastatic…

    Published on 2/1/2016
  • CLINICAL NEWS: UCSF CAR T tech doubles up on tumor specificity

    A paper published online Thursday in Cell said University of California San Francisco researchers engineered chimeric antigen receptor T cells that show anti-tumor activity only against target cells that express two …

    Published on 1/29/2016
  • CLINICAL NEWS: InflaRx reports first Phase IIa data for IFX-1 in sepsis

    InflaRx GmbH (Jena, Germany) said IFX-1 demonstrated "biological proof of concept" as a treatment for sepsis and met the primary endpoints in the German Phase IIa SCIENS trial. The double-blind, placebo-controlled study…

    Published on 1/28/2016
  • CLINICAL NEWS: Genticel's ProCervix misses HPV endpoint

    Genticel S.A. (Euronext:GTCL) said ProCervix (GTL001) missed the primary endpoint in the European Phase II RHEIA-VAC trial, which evaluated the potential of the bivalent therapeutic vaccine to prevent cervical cancer by…

    Published on 1/27/2016
  • CLINICAL NEWS: Incyte halts Jakafi substudy in mCRC

    Incyte Corp. (NASDAQ:INCY) slipped $9 (12%) to $65.99 in early after-hours trading after it said late Wednesday that it will stop early a substudy within a Phase II trial evaluating myelofibrosis drug Jakafi ruxolitinib…

    Published on 1/27/2016
  • CLINICAL NEWS: Vertex reports pediatric Orkambi data, earnings

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) reported earnings Wednesday and said Orkambi ivacaftor/lumacaftor met the primary safety endpoint but missed a secondary efficacy endpoint in a Phase III trial to treat cystic …

    Published on 1/27/2016
  • CLINICAL NEWS: Akashi halts DMD program

    Akashi Therapeutics Inc. (Cambridge, Mass.) said it suspended dosing and enrollment of all clinical studies of HT-100 to treat Duchenne muscular dystrophy after a patient experienced undisclosed "serious, life-…

    Published on 1/26/2016
  • CLINICAL NEWS: Galapagos' GLPG1205 fails in Phase IIa UC trial

    Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) said it will discontinue development of GLPG1205 to treat ulcerative colitis after the compound missed the efficacy endpoints in the Phase IIa ORIGIN trial. GLPG1205 did not …

    Published on 1/26/2016
  • CLINICAL NEWS: Medivation's pidilizumab on partial clinical hold

    Medivation Inc. (NASDAQ:MDVN) said FDA placed a partial clinical hold on an IND for pidilizumab (MDV9300) after the company disclosed the candidate is not an inhibitor of PD-1, as it had thought. FDA told Medivation to …

    Published on 1/25/2016
  • CLINICAL NEWS: Relypsa gains on DDI data

    Relypsa Inc. (NASDAQ:RLYP) gained $3.28 to $22.90 in early after-hours trading Monday after reporting data from Phase I drug-drug interaction studies of hyperkalemia drug Veltassa patiromer. Veltassa was approved in …

    Published on 1/25/2016
  • CLINICAL NEWS: NCI-Match extends pause in enrollment

    NIH's National Cancer Institute said it now plans to resume enrollment in the NCI-Match precision medicine trial in April or May, rather than restarting this month as it had expected. According to NCI's ECOG-ACRIN group…

    Published on 1/22/2016
  • CLINICAL NEWS: Janssen halts trials of FAAH inhibitor

    The Janssen Research & Development LLC unit of Johnson & Johnson suspended dosing of fatty acid amide hydrolase (FAAH) inhibitor JNJ-42165279 in two Phase II trials. The decision follows the death of a healthy volunteer…

    Published on 1/20/2016
  • CLINICAL NEWS: Eleven back to drawing board after Phase III miss

    Eleven Biotherapeutics Inc. (NASDAQ:EBIO) fell $1.82 (78%) to $0.52 on Monday after reporting that isunakinra (EBI-005) missed the primary endpoint in a 258-patient Phase III trial to treat moderate to severe allergic …

    Published on 1/19/2016
  • CLINICAL NEWS: Calibr researchers propose versatile CAR T strategy

    Two studies published in the Proceedings of the National Academy of Sciences describe a new chimeric antigen receptor (CAR) T cell antibody "switch" technology designed to improve safety and versatility of the cell …

    Published on 1/15/2016
  • CLINICAL NEWS: One volunteer brain-dead in Bial trial

    The French Health Ministry said a Phase I trial of the oral analgesic BIA 10-2474 from Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) has been halted after several healthy volunteers were hospitalized with …

    Published on 1/15/2016
  • CLINICAL NEWS: Grazax misses Phase III asthma prevention endpoint

    ALK-Abello A/S (CSE:ALK-B) said Grazax/Grastek (MK-7243) missed the primary endpoint of time to first diagnosis of reversible impairment of lung function vs. placebo in the Phase III GAP trial, which evaluated whether …

    Published on 1/14/2016
  • CLINICAL NEWS: Kite updates KTE-C19 data

    Kite Pharma Inc. (NASDAQ:KITE) gained $4.56 to $54.92 on Thursday after disclosing updated data from multiple trials of KTE-C19 in blood cancer patients who have been treated at NIH's National Cancer Institute. The …

    Published on 1/14/2016
  • CLINICAL NEWS: bluebird sinks after updating LentiGlobin timeline

    bluebird bio Inc. (NASDAQ:BLUE) lost $10.80 (19%) to $44.64, touching a 52-week low of $43.51 in intraday trading Monday after disclosing that it does not plan to provide updated data for LentiGlobin BB305 gene therapy …

    Published on 1/11/2016

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