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Applied Therapeutics Inc (APLT) Provides FDA Update on PDUFA Date for Govorestat

Applied Therapeutics Inc (APLT) Provides FDA Update on PDUFA Date for Govorestat
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Shoshana shendelmanCommittee for medicinal products human useDrug administrationTherapeutics incApplied therapeuticsNew drug applicationClassic galactosemiaPrescription drug user fee actMajor amendmentPriority reviewPediatric rare diseasePriority review voucherAldose reductase inhibitorGalactosemia kidsApplied therapeuticMarketing authorization application

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
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Advanz pharmaShoshana shendelmanMaeve conneightonDrug administrationHealth indexCommittee for medicinal products human useEuropean medicines agencyTherapeutics incExchange commissionAction dateNew drug applicationClassic galactosemiaPrescription drug user fee actApplied therapeuticsMajor amendmentPriority review

Applied Therapeutics (NASDAQ:APLT) Now Covered by Royal Bank of Canada

Applied Therapeutics (NASDAQ:APLT) Now Covered by Royal Bank of Canada
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United statesNova scotiaLeslied funtleyderShoshana shendelmanLeerink partnrsRenaissance technologiesRoyal bankSecurities exchange commissionTherapeutics incAcadian asset managementGoldman sachs group incBlackrock incApplied therapeuticsGet free reportExchange commissionAsset management

Applied Therapeutics (APLT) Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in SORD Deficiency

Applied Therapeutics (APLT) Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in SORD Deficiency
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Riccardo perfettiShoshana shendelmanHealth indexUniversity of iowa medical centerTherapeutics incDrug administrationApplied therapeuticsSorbitol dehydrogenaseAldose reductase inhibitorNew drug applicationAnalysis resultsChief medical officerMichael shyNeuromuscular medicineCarver collegeIowa medical center

ARISE-HF Phase 3 Trial Likely To Disappoint Due To Multiple Red Flags (NASDAQ:APLT)

ARISE-HF Phase 3 Trial Likely To Disappoint Due To Multiple Red Flags (NASDAQ:APLT)
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United statesShoshana shendelmanTherapeutics incAldose reductase inhibitorsNew drug applicationDiabetic cardiomyopathyApplied therapeuticCardiopulmonary exercise testKansas city cardiomyopathy questionnaireCardiac outputHeart rateStroke volumeArteriovenous oxygen differenceApplied therapeuticsZapolrestat structureDiscounted cash flow