2026年潜在关键新药上市预测与管线分析 Key Potential Drug Launches in 2026

KeyPotentialDrugLaunchesin2026

Asasupplementtoourwell-knownquarterlyOutlookreport,Biomedtrackerispleasedtopresentalonger-termlookatsomekeylate-stagedrugsprojectedtohitthemarketin2026.Thesedrugsrepresentnew

drugclasses,majorchangestostandardsofcare,and/orlargemarketopportunitiesacrossthewiderangeofindicationscoveredbyBiomedtrackerandDatamonitorHealthcare.

Thisreportwillenableyouto:

•Identifyhigh-impactlaunches-Discoverdrugsthatcouldachieveblockbusterpotential,transformtreatmentlandscapes,orlaunchinnewtherapeuticclasses.

•Anticipatecompetitiveshifts-Understandwhichtherapiesmaychangethestandardofcareanddisruptexistingmarkets.

•Trackkeyregulatorymilestones-Followcriticalcatalysts,includingPDUFAdates,pivotaltrialreadouts,andfirstapprovals.

•Supportstrategicdecisions-Leverageourexpertinsightstoenhanceportfolioplanning,competitorsmonitoring,anddriveinformedplanning.

•Accessconciseanalystinsights-Benefitfromclear,onesummariesforeachhighlighteddrugwiththerapyarea,companydetails,likelihoodofapproval,andlinkstodeeperanalysisonBMT.

MoredetailsabouteachdrugcanbeviewedonBiomedtrackerbyclickingthe7icon.

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Methodology

ScopeandObjective

ThisreporthighlightspharmaceuticalcandidatesthatwereinPhaseIIIorlaterstagesof

developmentasofJuly2025,withselectPhaseIIb/II/IIIdrugsincludedbasedonthepresence

ofnear-termregulatorycatalysts.Theprimaryobjectiveistoidentifydrugswithsignificantpotentialformarketimpact(blockbusterpotential),clinicalrelevance,andregulatoryadvancement.

SelectionCriteria

Drugswereselectedbasedonthefollowingcatalysts:

•ProductLaunchCatalysts

•ApprovalDecisionCatalysts

•RegulatoryFilingCatalysts(e.g.,NDA/BLAsubmissions)

•PhaseIIIorPivotalTrialReadouts

BlockbusterPotential

StrategicRelevance

Thereportfocusesondrugsthatdemonstrate:

•LargeMarketPotential(Blockbuster)

•MajorChangetoStandardofCare

•RepresentationofNovelDrugClasses

Thesecriteriaensurethatthereportcapturescandidateswiththehighestlikelihoodof

influencingbothclinicalpracticeandcommerciallandscapes.

Ablockbusterdrugisdefinedasonegenerating$1billionormoreinannualrevenue.Whileitremainsuncertainwhetheranyofthedrugslistedwillreachthisbenchmark,thereportaimstospotlightthosewithpotentialtodoso.

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Contents

Thisreportcoversthefollowingindications:

Allergy

•

Anaphylaxis

•

ChronicRhinosinusitis

Autoimmune/Immunology(A/I)

•

Dermatomyositis

•

MyastheniaGravis

•

PrimaryBiliaryCholangitis

•

PsoriaticArthritis

•

PulmonaryAlveolarProteinosis

•

Urticaria

Cardiovascular(CV)

•

AcuteCoronarySyndrome

•

Cardiomyopathy

-

Hypertrophic

•

CardiovascularDisease

•

ChronicHeartFailure

–

PreservedEjection

Fraction

•

ChronicHeartFailure

–

ReducedEjectionFraction

•

ChronicHeartFailureandCardiomyopathies

–

Unspecified

•

Dyslipidemia

/Hypercholesterolemia

•

Hypertension(Systemic)

•

PeripheralArteryDisease

Dermatology

•

AtopicDermatitis(Eczema)

–

Anzupgo

•

AtopicDermatitis(Eczema)

–

Rocatinlimab

•

AtopicDermatitis(Eczema)

–

Zoryve

Endocrine

•

Achondroplasia

•

Cushing’sSyndrome

•

DiabetesMellitus,Type

II

Hematology

•

HemophiliaA

InfectiousDiseases

•

COVID

-

19PreventionandSeasonalInfluenza

Vaccines

•

HIV/AIDSTreatment

•

UrinaryTractandReproductiveTractInfections

Clicktogodirectlytothecontentspage,anindicationordiseasegroup

Metabolic

•

DuchenneMuscularDystrophy

•

FamilialChylomicronemiaSyndrome

•

GlycogenStorageDisease

•

MucopolysaccharidosisII(MPSII;Hunter

Syndrome)

•

Obesity

–

Cagrisema

•

Obesity

–

Orforglipron

•

Obesity

–

Rybelsus

•

Porphyria

Neurology

•

AmyotrophicLateralSclerosis

•

Huntington’sDisease

•

MultipleSclerosis

•

Narcolepsy

–

AXS

-

12

•

Narcolepsy

–

Oveporexton

•

NeuropsychiatricsymptomsinAlzheimer’s

disease

•

Parkinson’sDisease

Oncology

•

AcuteLymphoblasticLeukemia

|

MyelodysplasticSyndrome|Acute

MyelogenousLeukemia

•

BladderCancer

•

ColorectalCancer

•

GastricCancer

•

HER2+BreastCancer

•

Melanoma

•

MultipleMyeloma

•

Non

-

smallCellLungCancer

–

Datroway

•

Non

-

smallCellLungCancer

–

Zipalertinib

•

OvarianCancer

•

PolycythemiaVera

•

ProstateCancer

•

RenalCellCarcinoma

•

SmallCellLungCancer

•

TripleNegativeBreastCancer

Psychiatry

•

MajorDepressiveDisorder

•

Schizophrenia

–

Brilaroxazine

•

Schizophrenia

–

TV

-

44749

Respiratory

•

Asthma

AllergyA&ICVDermatologyEndocrineHematologyInfectiousDiseasesMetabolicNeurologyOncologyPsychiatryRespiratory

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Allergy

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Allergy

ANAPHYLM|AQST|LOA:AVERAGE|BIOMEDTRACKERPROFILE

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Anaphylaxis

TheU.S.FoodandDrugAdministration(FDA)hasacceptedAquestiveTherapeutics’NewDrugApplication(NDA)forAnaphylmforthetreatmentofsevereallergicreactions.ThePrescriptionDrugUserFeeAct(PDUFA)targetactiondatehasbeensetforJanuary31,2026.Anaphylm(epinephrine)representsasignificant

advancementintheemergencytreatmentofsevereallergicreactions,oranaphylaxis.Thedrug'smostnotablefeatureisitsinnovativesublingualfilmdelivery

system.InApril2025,Anaphylmwasshowntomaintainitsconsistentpharmacokinetic(PK)profile,asseeninadults,inpediatricpatientsbetweentheagesofsevenandseventeenandweighingmorethanthirtykilograms.ThiscouldenableAnaphylmtohavealabelthatincludesthispediatricpatientpopulation.

ThemarketpotentialforAnaphylmissubstantialandisdrivenbyaclear,unmetmedicalneed.Whileepinephrineauto-injectorshavebeenthecornerstoneof

anaphylaxistreatmentforyears,theirlimitationsintermsofbulkinessanduseranxietyhaveresultedinasignificantnumberofindividualseithernotcarryingtheir

medicationregularlyorfailingtouseitcorrectlyduringanemergency.Thepopulationatriskofanaphylaxisislargeandgrowing,withmillionsofpeoplediagnosed

withseverefood,insectvenom,orotherallergies.Anaphylm’sdesigndirectlytargetsthiscomplianceissue.Byofferingaconvenientandlessintimidatingalternative,thedrugispoisedtoexpandthemarketbyincreasingadherenceamongexistingpatientsandbyencouragingawidergroupofat-riskindividualstocarrylife-savingmedication.Withitspotentialtobecomeapreferredfirst-linetherapy,Anaphylmiswell-positionedtocapturealargeshareofthemarket,offeringbothacommercialopportunityandasignificantpublichealthbenefit.

Tags:FirstApproval,PotentialBlockbuster,PracticeChanging

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Allergy

DEPEMOKIMAB|GSK|LOA:AVERAGE|BIOMEDTRACKERPROFILE

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ChronicRhinosinusitis

Depemokimabispoisedtobecomeasignificantnewtreatmentoptionforchronicrhinosinusitiswithnasalpolyps(CRSwNP),amajortype2inflammatorydisease.Thedrugisalong-actingmonoclonalantibodythattargetsinterleukin-5(IL-5),akeycytokineresponsiblefortheoverproductionofeosinophilsandisalsobeing

developedforsevereasthma.Whatdistinguishesdepemokimabfromotherbiologicsinthisclassisitsuniquetwice-yearlydosingschedule.Unlikeexisting

treatmentsthatrequiremorefrequentadministrationeveryfourtoeightweeks,depemokimab'slonghalf-lifeandhighpotencycouldofferamoreconvenientandpatient-friendlyexperience,potentiallyleadingtoimprovedlong-termadherenceandbetterdiseasemanagement.Thisisacriticalfactorforpatientswithchronicconditionsthatrequiresustainedmanagement.

TheU.S.FoodandDrugAdministration(FDA)hasacceptedaBiologicsLicenseApplication(BLA)forbothproposedindications,withaPrescriptionDrugUserFeeAct(PDUFA)datesetforDecember16,2025.Inclinicaltrials,depemokimabhasdemonstratedrobustefficacy,particularlyinCRSwNP.Foradultpatientswith

inadequatelycontrolledCRSwNP,thePhaseIIIANCHORtrialsmettheirco-primaryendpoints,showingsignificantimprovementsinbothnasalpolypsizeandnasalobstruction.Thesepositiveclinicalresults,combinedwiththedrug’shighlyconvenientdosingregimen,supportitspotentialtooffersustainedsymptom

improvementandreducetheburdenofthisdiseaseonpatientsandhealthcaresystems.ThedrugalsoshowedanotablereductioninasthmaattacksinitsPhaseIIISWIFTtrials.GSKestimatesthatintheUnitedStates,2.1%ofthepopulationisaffectedbychronicrhinosinusitis,upto30%ofwhomhavenasalpolyps.

Tags:FirstApproval,PotentialBlockbuster,PracticeChanging

AllergyA&ICVDermatologyEndocrineHematologyInfectiousDiseasesMetabolicNeurologyOncologyPsychiatryRespiratory

Autoimmune/Immunology

AllergyA&ICVDermatologyEndocrineHematologyInfectiousDiseasesMetabolicNeurologyOncologyPsychiatryRespiratory

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Autoimmune/Immunology

BREPOCITINIB|PRIOVANT|LOA:AVERAGE|BIOMEDTRACKERPROFILE

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Dermatomyositis

Brepocitinib(PF-06700841)isanovel,oral,once-dailydualTYK2andJAK1inhibitordevelopedbyPriovantTherapeutics.Itsdualmechanismisdesignedtoinhibitkeyproinflammatorycytokinepathwaysinvolvedinthepathogenesisofdermatomyositis(DM),arare,systemicautoimmunediseasecharacterizedbyhallmarkskinrashesandprogressiveproximalmuscleweakness.DMisassociatedwithsignificantmorbidity,includinginterstitiallungdisease,malignancy,andcardiac

complications,oftenresultinginfunctionalimpairmentandreducedqualityoflife.

Brepocitinibiscurrentlyinlate-stagedevelopmentfordermatomyositis,withtheVALORPhaseIIItrialevaluatingitssafety,efficacy,andtolerabilityinadultswith

activeskinandmuscledisease.Thestudyenrolled241patientsaged18to75yearsandisthelargestinterventionaltrialconductedinDMtodate.Theprimary

endpointisTotalImprovementScore(TIS)atWeek52,withsecondaryendpointsincludingmeasuresofskinandmuscleinvolvement,steroid-sparingeffects,organ-specificassessments,andpatient-reportedoutcomes.Toplinedataareexpectedinthesecondhalfof2025,withapotentialNewDrugApplication(NDA)submissiontofollow.

Giventherarityofdermatomyositisandtheabsenceofapprovedoraltargetedtherapies,brepocitinibrepresentsasignificanttherapeuticopportunity.Ifapproved,itwouldbecomethefirstdisease-modifyingoralagentspecificallydesignedtoaddresstheunderlyingimmunopathologyofDM,potentiallyofferingimprovedefficacy,safety,andconveniencecomparedtoexistingsystemicsteroidsandintravenoustherapies.

Tags:NewDrugClass,PracticeChanging

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Autoimmune/Immunology

UPLIZNA|AMGN|LOA:ABOVEAVERAGE|BIOMEDTRACKERPROFILE

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MyastheniaGravis

UPLIZNA(inebilizumab),developedbyAmgenforthetreatmentofgeneralizedMyastheniaGravis(gMG),isadministeredastwoinitialinfusionsonDay1andDay

15,followedbymaintenanceinfusionseverysixmonths.IntheUS,UPLIZNAisalreadyapprovedforNeuromyelitisOpticaSpectrumDisorderand,morerecently,forIgG4-relateddisease.

WhencomparedtocurrentlyapprovedandpipelinedrugsforMGthatfocusoncomplementinhibitionorFcRninhibition,UPLIZNAisananti-CD19monoclonal

antibodythatpresentsanoveltreatmentapproachbytargetingupstreamautoantibody-producingCD19+Bcells,includingplasmablastsandplasmacells,thus

potentiallyaddressingbothAChR+andMuSK+populations.Furthermore,UPLIZNA’stwice-a-yearmaintenanceinfusionsaremoreconvenientcomparedtoothertherapies,suchasSOLIRISandnipocalimab,whichrequireinfusionseverytwoweeks,andULTOMIRIS,whichisadministeredeverytwomonths.

TheMINTPhaseIIIpivotaltrialmetitsprimaryendpoint,withastatisticallysignificantchangefrombaselineinMG-ADLscoreforUPLIZNA(-4.2)comparedwith

placebo(-2.2)atWeek26forthecombinedstudypopulation.Additionally,UPLIZNAcontinuedtoshowsustainedsymptomimprovementoverplaceboinAChR+

myastheniagravispatientsthroughWeek52,basedonMG-ADLscores.ThecompanyalsostatedthattheUSFDAreviewoftheMINTPhaseIIIdatainpatientswithgMGisongoing,withaPDUFAdateofDecember14,2025.

Tags:LabelExpansion(NewIndication),PotentialBlockbuster

AllergyA/ICVDermatologyEndocrineHematologyInfectiousDiseasesMetabolicNeurologyOncologyPsychiatryRespiratory

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Autoimmune/Immunology

LINERIXIBAT|GSK|LOA:ABOVEAVERAGE|BIOMEDTRACKERPROFILE

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PrimaryBiliaryCholangitis

Linerixibat,anoral,investigational,first-in-class,minimallyabsorbedilealbileacidtransporter(IBAT)inhibitor,hasreceivedNewDrugApplication(NDA)acceptancefromtheU.S.FoodandDrugAdministration(FDA)forthetreatmentofcholestaticpruritusinpatientswithprimarybiliarycholangitis(PBC).Cholestaticpruritusisadebilitating,relentlessitchthataffectsasignificantportionofpatientswithPBC,arareautoimmuneliverdisease.Byblockingthereuptakeofbileacidsinthesmallintestine,linerixibatreducesthelevelsofthesepruritus-inducingsubstancesincirculation,therebyalleviatingtheitchingsensation.Thisapproachaddressesa

significantunmetneedforatargetedtreatment,ascurrenttherapiesareofteninadequateandhavelimitedimpactonpruritus.

TheNDAsubmissionissupportedbypositivedatafromthePhaseIIIGLISTENtrial,whichmetitsprimaryandkeysecondaryendpoints.Thetrialdemonstrateda

rapid,significant,andsustainedimprovementincholestaticpruritusanditch-relatedsleepinterferenceinpatientstreatedwithlinerixibatcomparedtoplacebo.Themostcommonadverseeventreportedwasdiarrhea,whichwasmostlymild.GSKestimatesthatapproximately70%ofpatientsreceivingfirst-linetreatmentforPBCachievediseasecontrolbutdonotexperienceareductionintheseverityorimpactofpruritus.TheFDAhasassignedaPrescriptionDrugUserFeeAct(PDUFA)

goaldateofMarch24,2026.Ifapproved,linerixibathasthepotentialtobecomeafoundationaltherapyforpatientsstrugglingwiththerelentlessitchassociatedwithPBC,offeringamuch-neededtreatmentoption.

Tags:NewDrugClass,FirstApproval,PotentialBlockbuster,PracticeChanging

AllergyA/ICVDermatologyEndocrineHematologyInfectiousDiseasesMetabolicNeurologyOncologyPsychiatryRespiratory

Autoimmune/Immunology

SOTYKTU|BMY|LOA:ABOVEAVERAGE|BIOMEDTRACKERPROFILE

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PsoriaticArthritis

SOTYKTU(deucravacitinib)isanoral,first-in-class,selectiveallostericTYK2inhibitor.Itisapprovedformoderate-to-severeplaquepsoriasis,andalthoughTYK2ispartoftheJAK/STATpathway,theUSPrescribingInformationdoesnotcontainaBoxedWarning(unlikeJAKinhibitors,whichcarryclassboxedwarnings).

Inpsoriaticarthritis(PsA),twoPhaseIIItrials(POETYKPsA-1andPsA-2)showedSOTYKTUachievingAmericanCollegeofRheumatology(ACR)responsecriteria20(ACR20)responsesatWeek16of54.2%forbothtrialsversusplacebo(34.1%and39.4%,respectively),maintainedthroughWeek52inPsA-2.AlthoughACR20wasmetastheprimaryendpoint,ACR50andACR70,oftenconsideredmoreclinicallyrelevant,were24.5%and11.6%,respectively,atWeek16,lowerthanJAK

inhibitorslikeXELJANZ(29%and20%,respectively,at12weeks)andRINVOQ15mg(38%and16%,respectively,at12weeks).Additionally,inPsA-1,radiographicprogressionatWeek16wasnotstatisticallysignificant,thoughposthocanalysesfavoredSOTYKTU.

TheregulatoryapplicationsfortheEU,Japan,China,andtheUSarebasedonpositiveresultsfromthepivotalPOETYKPsA-1andPsA-2trials.TheUSFDA

acceptedBMY’ssNDAapplicationonJuly21,2025,withaPDUFAgoaldateofMarch6,2026,forthetreatmentofadultswithactivepsoriaticarthritis.TheEMAvalidatedaTypeIIvariationforPsA,andJapan'sMinistryofHealth,LabourandWelfareacceptedtheapplication,bothinlinewiththeJuly2025announcement.

Asanoraltherapy,SOTYKTUsetsitselfapartfrommostcurrentPsAtreatments,whichareinjectable.Itsestablishedefficacyinpsoriasis,improvementsinarthritissymptoms,favorablesafetyprofile,andtheemergenceofotherTYK2inhibitorssuchasTakeda’sTAK-279indicatethatthisdrugclassmaybecomeavaluable

componentoffuturePsAtherapeuticapproaches.

Tags:LabelExpansion(NewIndication),PotentialBlockbuster

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Autoimmune/Immunology

MOLGRADEX|SVRA|LOA:ABOVEAVERAGE|BIOMEDTRACKERPROFILE

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PulmonaryAlveolarProteinosis

Molgradex(molgramostim)inhalationsolutionisanon-glycosylatedrecombinanthumanGM-CSF.SavaraisdevelopingthisinhaledtherapyforthetreatmentofAutoimmunePulmonaryAlveolarProteinosis(aPAP),aimingtoactivatelungmacrophagesandrestoretheirsurfactant-clearingfunctiontoimproveoxygenation.

MolgradexisadministeredusingtheinvestigationaleFlowNebulizerSystem(PARIPharmaGmbH),whichhasbeenspecificallyengineeredfortheinhalationdeliveryoflarge-moleculetherapeutics.

MolgradexhasreceivedOrphanDrugDesignationforaPAPfromboththeFDAandEMA,aswellasFastTrackandBreakthroughTherapydesignationsfromtheFDA.ItalsoholdstheInnovationPassportandPromisingInnovativeMedicinestatusfromtheUKMHRA.

TheconfirmatoryPhaseIIIIMPALA-2trialmetitsprimaryendpoint,demonstratinga9.8%improvementingastransferintheMolgradexarmversus3.8%inthe

placebogroup,asmeasuredbythechangefrombaselineinhemoglobin-adjustedpercentpredicteddiffusingcapacityofthelungsforcarbonmonoxide(DLco%)atWeek24.Theimprovementingastransfer,alongwithexercisecapacity,wasmaintainedthroughoneyearoftreatment.

InMay2025,SavarareceivedaRefuse-to-File(RTF)letterfollowingarollingBLAsubmissionlatelastyear.Thereasonwasrelatedtomanufacturingissues,not

concernsaboutsafetyorefficacy.ThecompanyplanstoresubmittheBLAtotheFDAbytheendofthisyearandaimstoapplyformarketingauthorizationwiththeEMAinQ12026.

Tags:FirstApproval,PracticeChanging

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Autoimmune/Immunology

REMIBRUTINIB|NVS|LOA:AVERAGE|BIOMEDTRACKERPROFILE

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Urticaria

Novartis’remibrutinib,anoralBruton’styrosinekinaseinhibitor(BTKi),iswell-positionedtobecomeaconvenientalternativetoexistingtherapiesinthechronic

spontaneousurticaria(CSU)landscape.Ifapproved,itwouldrepresentboththefirstapprovalforthedrugandthefirstoraltreatmentoptioninCSUafterpatientsfailtorespondtoantihistamines,markingapivotalshiftinthetherapeuticpathwaywherecurrentoptionsarelimitedtoparenteralbiologics.

NovartisconductedtwoPhaseIIItrials,REMIX-1andREMIX-2,bothinbio-naivepatientswho,despiteantihistamineuse,hadapoorresponse.BothPhaseIIItrials

achievedtheprimaryendpointofsignificantandclinicallymeaningfulimprovementsindiseaseactivity,measuredbytheabsolutechangeinUAS7(UrticariaActivityScore)atWeek12.Remibrutinibfaredwellinbothtrials,showinga20.1-pointdecreaseinUAS7scorefrombaselinecomparedtoa13.8-pointdecreaseseenintheplacebogroup(REMIX-1),anda19.8-pointdecreaseinUAS7scorefrombaselinecomparedtoan11.7-pointreductionseenintheplacebogroup(REMIX-2).

BeyondCSU,remibrutinibisalsobeingexploredacrossmultipleimmune-mediatedindications,includingfoodallergies,multiplesclerosis,andmyastheniagravis,whichcouldfurtherbroadenitslong-termclinicalandcommercialpotential.

Tags:NewDrugClass

AllergyA/ICVDermatologyEndocrineHematologyInfectiousDiseasesMetabolicNeurologyOncologyPsychiatryRespiratory

Cardiovascular

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Cardiovascular

FDY-5301|FARADAYPHARMACEUTICALS|LOA:ABOVEAVERAGE|BIOMEDTRACKERPROFILE

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AcuteCoronarySyndrome

Acutecoronarysyndrome(ACS)isacollectivetermforischemiccardiacevents,suchasunstableanginapectoris,ST-elevationmyocardialinfarction(STEMI),andnon-ST-elevationmyocardialinfarction(NSTEMI).Myocardialinfarction,commonlyreferredtoasaheartattack,isamajorcauseofmortalityworldwide.FollowinganacuteSTEMIevent,percutaneouscoronaryintervention(PCI)isthepreferredstrategyforrestoringbloodflowtotheheart,ormyocardialperfusion.However,therapid

reoxygenationoftissueafterPCIcaninduceexcessiveproductionofreactiveoxygenspecies(ROS),whichmaycontributetomyocardialreperfusioninjuryandconsequentcardiactissuedamage.

FDY-5301,FaradayPharmaceuticals,proprietaryformulationofsodiumiodide,actsasacatalystforconvertinghydrogenperoxide,amajorculpritROSinreperfusioninjury,intowaterandoxygen.Assuch,FDY-5301hasthepotentialtomitigateischemia-reperfusioninjury(IRI),addressingasignificantunmetneedgiventhecurrentabsenceofapprovedpharmacologictherapiesforIRI.

InthePhaseIIstudyofFDY-5301forthetreatmentofreperfusioninjuryfollowingSTEMI,theresultsindicatedanencouragingtrendtowardefficacy,evidencedbya

reductionininfarctsize(asaproportionoftheleftventricle)andimprovedcardiacfunctionaftertreatment.Generally,thesizeofinfarctionfollowingSTEMIisamajor

determinantofprognosis,andlargeinfarctionsareassociatedwithpoorrecovery.Althoughthestudyenrolledasmallpopulation,thesefindingsarepromisingandsuggestthatFDY-5301couldimproveprognosisforpatients.Importantly,FDY-5301waswelltolerated,withnoevidenceofincreasedriskofclinicallysignificantarrhythmias.

Buildingontheseresults,FaradayPharmaceuticalsinitiatedaPhaseIIIstudyentitledIOCYTEAMI-3,withthegoalofrecruiting2,300anteriorSTEMIpatientstofully

assessFDY-5301,seffectsonclinicaloutcomes.DatafromthispivotalstudyareexpectedinH22025,raisingthepossibilityof