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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Tonix plummets on Phase IIb miss

    Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) fell $7.01 (50%) to $6.95 on Monday after its TNX-102 SL missed the primary endpoint in a Phase IIb trial to treat fibromyalgia. In the 205-patient BESTFIT study, 2.8 mg…

    Published on 9/29/2014
  • CLINICAL NEWS: Repros gains on second Androxal Phase III

    Repros Therapeutics Inc. (NASDAQ:RPRX) gained $1.52 (17%) to $10.48 on Friday after its Androxal enclomiphene met both primary endpoints in the Phase III ZA-304 trial to treat secondary hypogonadism, which measured the …

    Published on 9/26/2014
  • CLINICAL NEWS: Novartis' secukinumab meets in Phase III

    Novartis AG (NYSE:NVS;SIX:NOVN) said secukinumab (AIN457) met the primary endpoint of improving ACR20 response rate in two Phase III studies to treat psoriatic arthritis. Full trial results will be presented at an …

    Published on 9/25/2014
  • CLINICAL NEWS: Gilead's TAF-based regimen meets Phase III endpoint

    Gilead Sciences Inc. (NASDAQ:GILD) said a tenofovir alafenamide (TAF)-based regimen met the primary endpoint of non-inferiority to Gilead's Stribild in two identical Phase III trials to treat HIV-1 infection in …

    Published on 9/24/2014
  • CLINICAL NEWS: DBV jumps on peanut allergy data

    DBV Technologies (Euronext:DBV) jumped EUR 5.82 (23%) to EUR 31.24 on Tuesday after reporting Phase IIb data for Viaskin Peanut (DBV-712) on Monday. At the high dose of 250 ug, Viaskin Peanut met its primary endpoint …

    Published on 9/23/2014
  • CLINICAL NEWS: More mixed data for Egalet's analgesic

    Egalet Corp. (NASDAQ:EGLT) said 15 mg Egalet-001 missed one endpoint for bioequivalence to 15 mg MS Contin morphine sulfate controlled-release oral tablets from Purdue Pharma L.P. (Stamford, Conn.). In Study 067-EG-006,…

    Published on 9/23/2014
  • CLINICAL NEWS: ZS Pharma jumps on ZS-9 Phase III data

    ZS Pharma Inc. (NASDAQ:ZSPH) gained $3.69 (11%) to $38.05 on Tuesday after announcing positive Phase III data for lead candidate ZS-9 sodium zirconium cyclosilicate for hyperkalemia. Preliminary results from the …

    Published on 9/23/2014
  • CLINICAL NEWS: Threshold down on Phase III data delay

    Threshold Pharmaceuticals Inc. (NASDAQ:THLD) fell $0.50 (11%) to $3.97 on Monday after saying it expects delayed data from its Phase III trial of TH-302 to treat unresectable or metastatic soft tissue sarcoma (STS).The …

    Published on 9/22/2014
  • CLINICAL NEWS: Flexion falls on FX006 trial hold

    Flexion Therapeutics Inc. (NASDAQ:FLXN) fell $4.38 (23%) to $15.00 in early after-hours trading on Wednesday on post-market news that FDA placed a clinical hold on an ongoing Phase IIb trial of FX006 to treat …

    Published on 9/17/2014
  • CLINICAL NEWS: Gilead's simtuzumab misses in pancreatic cancer

    Gilead Sciences Inc. (NASDAQ:GILD) said simtuzumab (GS-6624) missed the primary endpoint of progression-free survival (PFS) in a Phase II trial to treat patients with advanced pancreatic cancer.Patients received …

    Published on 9/17/2014
  • CLINICAL NEWS: Delenex's DLX105 misses in psoriasis Phase II

    Delenex Therapeutics AG (Zurich, Switzerland) said DLX105 led to no significant clinical improvements in a Phase II trial in mild to moderate plaque psoriasis. The co-primary efficacy endpoints were local Psoriasis Area…

    Published on 9/12/2014
  • CLINICAL NEWS: Lilly's ramucirumab meets Phase III colorectal endpoint

    Eli Lilly and Co. (NYSE:LLY) said ramucirumab plus chemotherapy increased overall survival, the primary endpoint, in a Phase III trial as second-line therapy for metastatic colorectal cancer (mCRC). The company declined…

    Published on 9/12/2014
  • CLINICAL NEWS: Tecemotide discontinued in NSCLC

    Oncothyreon Inc. (NASDAQ:ONTY) said in an SEC filing that partner Merck KGaA (Xetra:MRK) will stop development of tecemotide (L-BLP25) as a monotherapy for non-small cell lung cancer (NSCLC). The compound was in Phase …

    Published on 9/12/2014
  • CLINICAL NEWS: Bausch + Lomb option to MIM-D3 terminated

    Mimetogen Pharmaceuticals Inc. (Montreal, Quebec) said an option was terminated Aug. 31 that would have allowed the Bausch + Lomb Inc. unit of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) to take …

    Published on 9/11/2014
  • CLINICAL NEWS: More RPC1063 data boosts Receptos

    Investors have added $364 million in market cap to Receptos Inc. (NASDAQ:RCPT) over the past two days after the biotech provided the first look at annualized relapse rates (ARRs) for RPC1063 in multiple sclerosis, along…

    Published on 9/11/2014
  • CLINICAL NEWS: Serono providing funding for real-world MS study

    EMD Serono Inc. is providing at least $1 million in funding to the Accelerated Cure Project (ACP) for Multiple Sclerosis for the non-profit's longitudinal U.S. study focused on obtaining real-world data from MS patients…

    Published on 9/11/2014
  • CLINICAL NEWS: First Phase III data for Mimetogen's dry eye compound

    Mimetogen Pharmaceuticals Inc. (Montreal, Quebec) reported top-line data from a Phase III trial of MIM-D3 for dry eye, but did not report data from a second endpoint listed for the study on clinicaltrials.gov.The …

    Published on 9/10/2014
  • CLINICAL NEWS: Moxifloxacin regimens miss Phase III endpoint

    The not-for-profit Global Alliance for TB Drug Development said use of moxifloxacin in combination regimens did not shorten treatment time in tuberculosis patients, compared with standard of care (SOC) regimens. In the …

    Published on 9/8/2014
  • CLINICAL NEWS: China to manufacture Ebola treatment

    China Central Television said the country approved manufacturing of selective RNA polymerase inhibitor JK-05 for emergency use to treat Ebola cases within China's People's Liberation Army.According to CCTV news, the …

    Published on 9/5/2014
  • CLINICAL NEWS: FDA lifts partial hold on OncoMed's ipafricept

    OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) said FDA lifted a partial hold on Phase Ib trials of oncology candidate ipafricept (Fzd8-Fc, OMP-54F28), a Wnt signaling antagonist. The agency placed the hold in June after …

    Published on 9/4/2014
  • CLINICAL NEWS: Lilly's Peglispro superior to Lantus in Type I diabetics

    Eli Lilly and Co. (NYSE:LLY) said once-daily basal insulin peglispro (LY2605541) met the primary endpoint of non-inferiority to Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) in reducing HbA1c from …

    Published on 9/4/2014
  • CLINICAL NEWS: Antisense reports acromegaly data

    Antisense Therapeutics Ltd. (ASX:ANP) said 200 mg of ATL1103 twice-weekly met the primary endpoint in a 26-patient, open-label Phase II trial to treat acromegaly. That dosage reduced serum insulin-like growth factor-1 (…

    Published on 9/3/2014
  • CLINICAL NEWS: Edison's EPI-743 misses Rett syndrome endpoint

    Edison Pharmaceuticals Inc. (Mountain View, Calif.) said EPI-743 missed the primary endpoint of improving the Rett Syndrome Clinical Severity Scale score vs. placebo in a Phase II trial. The compound did meet a …

    Published on 9/3/2014
  • CLINICAL NEWS: Flexion provides FX006 update

    Flexion Therapeutics Inc. (NASDAQ:FLXN) said it now expects to complete Phase III development of FX006 to treat moderate to severe osteoarthritis (OA) knee pain by the end of 2015 -- a year earlier than the company had …

    Published on 9/3/2014
  • CLINICAL NEWS: Sanofi dengue vaccine meets Phase III endpoint

    Sanofi (Euronext:SAN; NYSE:SNY) said its dengue vaccine met the primary endpoint vs. placebo in a Phase III trial. The subcutaneous vaccine reduced symptomatic, virologically confirmed dengue fever cases by 60.8% vs. …

    Published on 9/3/2014

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