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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Sage soars on early postpartum depression data

    Sage Therapeutics Inc. (NASDAQ:SAGE) jumped $11.33 (15%) to $86.48 after reporting data from four patients in an exploratory open-label trial of SAGE-547 to treat postpartum depression. Within 24 hours of treatment with…

    Published on 6/9/2015
  • CLINICAL NEWS: Aimmune reports Phase II peanut allergy data

    Aimmune Therapeutics Inc. (Brisbane, Calif.) reported results from the Phase II ARC001 study of AR101 to treat peanut allergy.The company said that all 23 patients who completed treatment with AR101 met the primary …

    Published on 6/8/2015
  • CLINICAL NEWS: FDA places partial clinical hold on Neurocrine's NBI-77860

    Neurocrine BioSciences Inc. (NASDAQ:NBIX) fell $2.27 to $43.01 in after-hours trading on Monday after it said FDA placed a partial clinical hold on NBI-77860, its candidate to treat congenital adrenal hyperplasia (CAH).…

    Published on 6/8/2015
  • CLINICAL NEWS: Acucela gains on Phase II emixustat data

    Acucela Inc. (Tokyo:4589) gained Y45 to Y740 after emixustat (ACU-4429) demonstrated dose-dependent and reversible suppression of rod photoreceptor sensitivity in a Phase IIa trial to treat geographic atrophy (GA) …

    Published on 6/4/2015
  • CLINICAL NEWS: Imbruvica beats chlorambucil in Phase III CLL/SLL trial

    The Pharmacyclics LLC subsidiary of AbbVie Inc. (NYSE:ABBV) said Imbruvica ibrutinib met primary and secondary endpoints in its final analysis of the Phase III RESONATE-2 trial. The study compared Imbruvica with …

    Published on 6/4/2015
  • CLINICAL NEWS: ASCO launches TAPUR trial

    The American Society of Clinical Oncology launched the Targeted Agent and Profiling Utilization Registry (TAPUR) trial, a study of off-label uses of targeted therapies. TAPUR will collect real world clinical outcomes …

    Published on 6/1/2015
  • CLINICAL NEWS: BMS regains ground after Friday Opdivo-related losses

    Bristol-Myers Squibb Co. (NYSE:BMY) gained $1.88 to $66.48 on Monday, recovering $3 billion of the $7.5 billion in market cap it lost on Friday when data showed its Opdivo nivolumab appeared to lose a competitive edge …

    Published on 6/1/2015
  • CLINICAL NEWS: CTI gains on additional Phase III pacritinib data in MF

    CTI BioPharma Corp. (NASDAQ:CTIC) gained $0.23 (12%) to $2.17 on Monday after unveiling detailed data from the Phase III PERSIST-1 trial of pacritinib to treat patients with primary or secondary myelofibrosis (MF), in …

    Published on 6/1/2015
  • CLINICAL NEWS: Gazyva combo tops Treanda alone in indolent NHL

    Data from a Phase III study of Gazyva obinutuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) showed that Gazyva plus Treanda bendamustine followed by Gazyva alone significantly reduced the risk of …

    Published on 6/1/2015
  • CLINICAL NEWS: ImmunoGen posts big gain on ovarian cancer data

    ImmunoGen Inc. (NASDAQ:IMGN) surged $6.46 (72%) to $15.44 on Monday after data from a Phase I study showed antibody-drug conjugate mirvetuximab soravtansine (IMGN853) led to a 53% objective response rate (ORR) among …

    Published on 6/1/2015
  • CLINICAL NEWS: J&J reports Phase III CLL, SLL data for Imbruvica combo

    Johnson & Johnson (NYSE:JNJ) released data from a Phase III trial showing that patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving Imbruvica ibrutinib plus bendamustine and …

    Published on 6/1/2015
  • CLINICAL NEWS: Merck's MK-2206 graduates from I-SPY 2

    QuantumLeap Healthcare Collaborative said MK-2206 from Merck & Co. Inc. (NYSE:MRK) graduated from the adaptive Phase II I-SPY 2 trial to treat patients with hormone receptor (HR)-negative, HER2-positive, and HR-negative…

    Published on 6/1/2015
  • CLINICAL NEWS: NCI-MATCH trial to begin in July

    The NCI's National Clinical Trials Network (NCTN) said patient enrollment will begin in July for the Phase II NCI-MATCH trial, intended to determine whether cancer therapies can be targeted effectively to specific …

    Published on 6/1/2015
  • CLINICAL NEWS: Pfizer's Ibrance shows PFS benefit in PALOMA-3

    In the Phase III PALOMA-3 study, Ibrance palbociclib from Pfizer Inc. (NYSE:PFE) more than doubled progression-free survival (PFS) in patients with estrogen receptor-positive, epidermal growth factor receptor 2 (HER2)-…

    Published on 6/1/2015
  • CLINICAL NEWS: Farydak/Kyprolis ORR tops Velcade combo in MM

    Data due to be presented Tuesday at the American Society of Clinical Oncology meeting in Chicago showed a combination of Farydak panobinostat from Novartis AG (NYSE:NVS; SIX:NOVN) and Kyprolis carfilzomib from Amgen Inc…

    Published on 5/29/2015
  • CLINICAL NEWS: Keytruda data show correlation with MMR biomarker

    Merck and Co. Inc. (NYSE:MRK) announced the first clinical results showing a correlation of benefit from treatment with PD-1 inhibitor Keytruda pembrolizumab in patients with DNA mismatch repair (MMR) deficiency. In a …

    Published on 5/29/2015
  • CLINICAL NEWS: Aegerion to prep Japanese lomitapide NDA on new data

    Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) said lomitapide met the primary endpoint in a Japanese open-label Phase III trial to treat homozygous familial hypercholesterolemia (hoFH).The primary endpoint of the nine-…

    Published on 5/26/2015
  • CLINICAL NEWS: CBMG takes ride on CAR data

    Cellular Biomedicine Group Inc. (NASDAQ:CBMG) gained $4.51 (14%) to $35.64 on news its chimeric antigen receptor (CAR) T cell therapy targeting CD30 led to partial responses in two of seven patients in a Phase I study …

    Published on 5/22/2015
  • CLINICAL NEWS: Otonomy preps for Phase III despite Meniere's miss

    Otonomy Inc. (NASDAQ:OTIC) fell $6.19 (20%) to $24.86 on Friday after its OTO-104 missed the primary endpoint in a Phase IIb study to treat unilateral Meniere's disease. Based on positive trends and secondary endpoint …

    Published on 5/22/2015
  • CLINICAL NEWS: bluebird climbs on first LentiGlobin sickle cell data

    bluebird bio Inc. (NASDAQ:BLUE) climbed $7.23 to $172.94 on Thursday after the company disclosed the first efficacy data for a sickle cell disease (SCD) patient treated with its LentiGlobin BB305 gene therapy. The data …

    Published on 5/21/2015
  • CLINICAL NEWS: Calithera gains on Phase I leukemia data

    Calithera Biosciences Inc. (NASDAQ:CALA) rose $1.17 (11%) to $12.02 on Thursday after it said one patient had a complete response among 15 efficacy-evaluable patients in a Phase I trial of CB-839 to treat relapsed or …

    Published on 5/21/2015
  • CLINICAL NEWS: Sarilumab meets Phase III RA endpoints

    Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said sarilumab (REGN88, SAR153191), a human mAb against the IL-6 receptor, met both co-primary efficacy endpoints in the Phase III SARIL-…

    Published on 5/21/2015
  • CLINICAL NEWS: Genocea rises on Phase II HSV data

    Genocea Biosciences Inc. (NASDAQ:GNCA) gained $0.94 to $11.59 on Tuesday after it said all six dosing combinations that included lead candidate GEN-003 met the primary endpoint in a Phase II dose optimization trial to …

    Published on 5/20/2015
  • CLINICAL NEWS: Prima posts big gain on CVac's survival trend

    Prima BioMed Ltd. (ASX:PRR; NASDAQ:PBMD) surged $4.31 (269%) to $5.91 on NASDAQ on Wednesday after reporting final subset analyses from a Phase II ovarian cancer trial that missed its primary progression-free survival (…

    Published on 5/20/2015
  • CLINICAL NEWS: Intercept falls on Phase III NASH trial design

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) shed $50.48 (16%) to $263.50 on Tuesday after announcing the design of its Phase III REGENERATE trial of obeticholic acid (OCA) to treat non-alcoholic steatohepatitis (NASH).…

    Published on 5/19/2015

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