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Sarepta Therapeutics (SRPT) Q2 2022 Earnings Call Transcript

SRPT earnings call for the period ending June 30, 2022.

United statesLouise rodino klapacIan estepanDoug ingramMary jenkinsOffice of tissueExchange commissionSarepta therapeuticsDallan murraySarepta therapeutic second quarterResults conferenceBiologics license applicationAccelerated approvalAdvanced therapiesDrug evaluationScientific officer

With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

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Sarepta Therapeutics (SRPT) Investigational Gene Therapy SRP-9001 for DMD Demonstrates Significant Functional Improvements Across Multiple Studies

Sarepta Therapeutics (SRPT) Investigational Gene Therapy SRP-9001 for DMD Demonstrates Significant Functional Improvements Across Multiple Studies
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As muscular dystrophy drug meets key goal, Italfarmaco plans march forward to regulators

A Duchenne muscular dystrophy drug candidate from Italfarmaco Group has encouraging preliminary data from a pivotal study. The Milan, Italy-based pharmaceutical company says it now plans to meet with U.S. and European authorities about seeking regulatory approval for the small molecule.

United kingdomUnited statesLouise rodino klapacPaolo betticaItalfarmaco group duchenneItalfarmaco groupParent project muscular dystrophySarepta therapeuticsSolid biosciencesChief scientific officer louise rodino klapacChief medical officer paolo betticaWeight lossMedical devicesHealthcare innovationMedcity newsMedcity news

Sarepta Says FDA Put Clinical Hold on Duchenne MD Drug, Shares Fall 8%

Sarepta Says FDA Put Clinical Hold on Duchenne MD Drug, Shares Fall 8%
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