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Even after primary miss, Sarepta to seek wider Elevidys approval

Even after primary miss, Sarepta to seek wider Elevidys approval
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Louise rodino klapacDoug ingramAfter sareptaNorth star ambulatory assessment

Sarepta gene therapy for Duchenne misses main goal of key study

BioPharma

Doug ingramPeter marksLevi garrawayDrug administrationSarepta therapeuticNorth star ambulatory assessmentBiologics evaluationResaerch director peter marksSarepta mondayRoche chief medical officer levi garrawayClinical trialsGene therapy

Sarepta Stock Sinks on Mixed Gene Therapy Results

In a gene therapy study for patients with Duchenne muscular dystrophy, the primary endpoint was not met.

Emily dattiloDoug ingramDrug administrationSarepta therapeuticsNorth star ambulatory assessmentPresident doug ingramArticle normalBiotechnology servicesHealthcare life sciencesBiological therapyHealthcare provisionPolitical general newsGenetic disordersMedical conditionsMedical treatments proceduresBiotech and pharma

Sarepta Therapeutics shares plunge as gene therapy trial falls short of primary goal

Company plans to seek label expansion for Duchenne muscular dystrophy treatment

Doug ingramSarepta therapeutics incSarepta therapeuticsDrug administrationArticle normalBiotechnology servicesHealthcare life sciencesCorporate strategy planningCapacity facilitiesCorporate industrial newsPolitical general newsGenetic disordersMedical conditionsMedical treatments proceduresSarepta therapeutics incCorporate strategy

Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease. Analysts say prospects of the therapy, Elevidys, rest on FDA willingness to exercise flexibility it has already shown to rare disease drugmakers, including Sarepta.

United kingdomJoseph schwartzTim lugoDoug ingramWilliam blairReata pharmaceuticalsSarepta therapeuticsSarepta presidentMassachusetts based sareptaElevidys phaseWeight lossMedical devicesHealthcare innovationMedcity newsMedcity newsSan francisco

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