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Reduction of neurofilaments, a biomarker of neuronal death, after 6 months of treatment Stabilization of motor symptoms for treated patients in comparison to the decline expected with the. | June 14, 2023

United statesFrance generalMathieu charvMarie sebilleBatten disease foundationInternational congress on neuronal ceroid lipofuscinosesNational organization for rare disordersAtomic energy commissionBeyond batten disease foundationTheranexu chief medical officer marie sebilleInternational congressNeuronal ceroid lipofuscinosesUnified batten disease rating scaleFrench alternative energiesEuronext growthRare disorders

THERANEXUS: Theranexus and BBDF win FDA approval on efficacy endpoints for the Phase III trial to evaluate Batten-1 in CLN3 Batten disease

Phase III's primary endpoint will be visual acuity, with secondary endpoints including assessment of cognitive and motor functions, The FDA confirmed that this sole Phase III trial would secure

United statesFrance generalCraig bensonMarie sebilleMathieu charvFlorence portejoieThierry lambertMartin pierre laurentDrug administrationAtomic energy commissionDivision of rare diseasesNational organization for rare disordersBatten disease foundationBeyond batten disease foundationRare diseasesMedical genetics

Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the

Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the .

United statesMathieu charvCraig bensonMarie sebilleDivision of rare diseasesBatten disease foundationDrug administrationNews networkBeyond batten disease foundationRare diseasesMedical geneticsTheranexu chief medical officer marieVerbal comprehension indexWechsler intelligence scaleUnified batten disease rating scale

Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the Phase III Trial to Evaluate Batten-1 in CLN3 Batten Disease

Phase III's primary endpoint will be visual acuity, with secondary endpoints including assessment of cognitive and motor functions,The FDA confirmed that this sole Phase III trial would secure Batten-1

United statesFrance generalMarie sebilleMathieu charvCraig bensonMartin pierre laurentFlorence portejoieThierry lambertAtomic energy commissionDrug administrationBatten disease foundationDivision of rare diseasesNational organization for rare disordersBeyond batten disease foundationRare diseasesMedical genetics

CORRECTION FROM SOURCE: Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the Phase III Trial to Evaluate Batten-1 in CLN3 Batten Disease

This press release updates an earlier issuance with updated language throughout.Phase III's primary endpoint will be visual acuity, with secondary endpoints including assessment of cognitive and motor

United statesFrance generalMartin pierre laurentMathieu charvMarie sebilleCraig bensonFlorence portejoieThierry lambertAtomic energy commissionBatten disease foundationNational organization for rare disordersDivision of rare diseasesDrug administrationBeyond batten disease foundationRare diseasesMedical genetics

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