AnticipatedNear-TermMilestonesCompletionoffeasibilitystudiesforthehydrogeldepotdeliveringanti-VEGFdrugsincollaborationwithseveralpharmaceuticalpartners,expectedinthefirstquarterof2015.Phase3resultsofOTX-DPforthetreatmentofpost-operativeocularinflammationandpain,expectedinthefirstquarterof2015,andassumingfavorableresultsthesubmissionofanNDAtotheFDA,expectedinthesecondquarterof2015.[
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NewLinkGeneticsCorporationReportsThirdQuarter2014FinancialResultsAMES,Iowa,Nov.6,2014(GLOBENEWSWIRE)--NewLinkGeneticsCorporation(Nasdaq:NLNK),todayreportedconsolidatedfinancialresultsforthethirdquarterof2014andprogressinitsclinicalandbusinessdevelopmentprograms."AsweannouncedinAugust,wecontinuetodevelopthesciencearoundcombiningourIDOpathwayproductcandidateswithtreatmentmodalitiesincludingothe...[
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"WewereencouragedtofindthattheCTCsub-studyconfirmedthepresenceofseveralpotentialtarget-specificpharmacodynamicbiomarkers,suchastopoisomerase1,inthepatientsenrolledinourstudy,"saidIvanGergel,MD,seniorvicepresidentdrugdevelopmentandchiefmedicalofficerofNektarTherapeutics."TheanalysisfromtheBEACONCTCsub-studycouldhelpusbetterunderstandwhichadditionalpatientpopulationswouldbenefitfromNK...[
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UpcomingMilestonesMerrimackanticipatesthefollowingupcomingmilestones:PresentationofupdatedMM-398Phase3NAPOLI-1resultsatASCOGIinJanuary2015;SubmissionofaNewDrugApplicationtotheFDAforMM-398;AnnouncementoftoplinedatafromthePhase2clinicaltrialofMM-111ingastric,esophagealandgastroesophagealcancersin2015;andInitiationofaPhase2clinicaltrialofMM-141infrontlinepancreaticcancerin2015.[
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ARRY-797(ARRY-371797)–Phase2trialenrollingpatientswithLMNA-relateddilatedcardiomyopathy(DCM)Arrayisenrollinga12-patientPhase2study(NCT02057341)toevaluatetheeffectivenessandsafetyofARRY-797inpatientswithLMNA-relatedDCM,aserious,geneticcardiovasculardisease.Byage45,approximately70%ofpatientswithLMNA-relatedDCMexperiencecardiovasculardeath,transplantoramajorcardiacevent.Arrayplanstoprovideanupd...[
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CLEVELAND,Dec.29,2014(GLOBENEWSWIRE)--Athersys,Inc.(Nasdaq:ATHX)todayannouncedthatithasconcludedpatientenrollmentofitsPhase2clinicalstudyinvolvingadministrationofAthersys'MultiStem®celltherapytoischemicstrokepatients.Thestudyisarandomized,double-blind,placebo-controlled,multi-centerclinicaltrialevaluatingthesafetyandefficacyofMultiStemtherapyinsubjectssufferingmoderatetomoderate-severeischemic...[
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ThirdQuarterDevelopmentProgramHighlights
InJuly,EsperioninitiatedenrollmentinETC-1002-014,aPhase2studyin144patientswithhypercholesterolemiaandhypertension.Therandomized,double-blind,parallelgroup,multicenterstudyisevaluating180mgofETC-1002asmonotherapyascomparedwithplaceboforsixweeks.Top-lineresultsareexpectedinQ22015.
OnOctober1st,Esperionannouncedpositivetop-lineresultsfromtheETC-1002-008,Ph...[
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Anti-LINGODyaxlicenseeBiogenIdecInc.(Biogen)hasstatedthattheirPhase2clinicaltrialinacuteopticneuritiswithanti-LINGO,afullyhumanmonoclonalantibodythattargetsLINGO-1,isfullyenrolled.Biogenhasalsostatedthattheyexpecttodisclosetop-lineresultsfromthestudy,whichisreferredtoasRENEW,inearly2015.In2013,Biogeninitiatedarandomized,double-blind,parallel-group,dose-rangingPhase2clinicaltrialinvestigatinganti-L...[
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