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Sarepta Therapeutics (SRPT) Announces FDA Acceptance of an Efficacy Supplement to Expand the ELEVIDYS Indication

Sarepta Therapeutics (SRPT) Announces FDA Acceptance of an Efficacy Supplement to Expand the ELEVIDYS Indication
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Doug ingramDrug administrationSarepta therapeutics incSarepta therapeuticsBiologics license applicationEfficacy supplementPriority review

Sarepta Therapeutics Announces U S FDA Acceptance of an Efficacy Supplement to Expand the ELEVIDYS Indication

– Priority review granted, with a review goal date of June 21, 2024 .

United statesDoug ingramSarepta therapeutics incExchange commissionDrug administrationTrademark officeSarepta therapeuticsBiologics license applicationEfficacy supplementPriority reviewSerious liver injuryPrecision genetic medicine engineFor investorUnited states patentAnnual report

Prospects Look Better for Sarepta Gene Therapy, Sending the Stock Up Again

Investors looking for signs the FDA will let more patients use Sarepta Therapeutics’ Duchenne muscular dystrophy treatment got exactly that.

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Sarepta s Elevidys expansion bid gets fast review without adcomm

Sarepta s Elevidys expansion bid gets fast review without adcomm
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Why Is Sarepta Therapeutics Stock Trading Higher Today? - Sarepta Therapeutics (NASDAQ:SRPT)

Sarepta's Elevidys efficacy supplement accepted for Duchenne muscular dystrophy treatment expansion, potential $1 billion yearly opportunity. FDA review goal: June 21, 2024.

William blairDoug ingramRoche holdingsSarepta therapeutics incBiologics license applicationEfficacy supplementPriority reviewSarepta therapeutics