Drugs / ELEVIDYS
last change Jul 2026 re-read 3 minutes ago

ELEVIDYS

Developed for
Duchenne muscular dystrophy
Investigated by
Sarepta Therapeutics, Inc.

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Refused (EMA) EU (EMA) Elevidys — 2025-09-24 europa.eu ↗

Trials 1

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT07542314 Jul 2026 → Mar 2027 expected Duchenne muscular dystrophy Sarepta Therapeutics, Inc. Not yet recruiting No outcome recorded

Press releases naming this drug 22 releases

DateIssuerRelease
2026-03-16 Sarepta Therapeutics, Inc. Sarepta Announces that Screening and Enrollment are Underway in ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with Duchenne sarepta.com ↗
2026-02-24 Sarepta Therapeutics, Inc. Sarepta Therapeutics Announces Commercial Launch of ELEVIDYS in Japan sarepta.com ↗
2026-01-26 Sarepta Therapeutics, Inc. Sarepta Announces Positive Topline Three-Year EMBARK Results Showing ELEVIDYS Significantly Slows Disease Progression on Key Functional Measures in Ambulatory Duchenne Patients sarepta.com ↗
2026-01-23 Sarepta Therapeutics, Inc. Sarepta Therapeutics to Report 3-Year Topline Data from EMBARK Study of ELEVIDYS Gene Therapy in Ambulatory Individuals with Duchenne Muscular Dystrophy sarepta.com ↗
2025-11-25 Sarepta Therapeutics, Inc. Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with Duchenne sarepta.com ↗
2025-11-14 Sarepta Therapeutics, Inc. Sarepta Announces FDA’s Approval of Updated ELEVIDYS Prescribing Information sarepta.com ↗
2025-07-28 Sarepta Therapeutics, Inc. FDA Informs Sarepta That It Recommends That Sarepta Remove Its Pause and Resume Shipments of ELEVIDYS for Ambulatory Individuals With Duchenne Muscular Dystrophy sarepta.com ↗
2025-07-25 Sarepta Therapeutics, Inc. Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS sarepta.com ↗
2025-07-25 Sarepta Therapeutics, Inc. Sarepta Therapeutics Acknowledges CHMP Negative Opinion for ELEVIDYS in the European Union sarepta.com ↗
2025-07-21 Sarepta Therapeutics, Inc. Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S. sarepta.com ↗
2025-07-18 Sarepta Therapeutics, Inc. Sarepta Therapeutics Provides Statement on ELEVIDYS sarepta.com ↗
2025-07-16 Sarepta Therapeutics, Inc. Sarepta Therapeutics Announces Strategic Restructuring and Pipeline Prioritization Plan to Maintain Long-term, Sustainable Growth and Provides Update on ELEVIDYS Label sarepta.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as ELEVIDYS ClinicalTrials.gov intervention name — accepted as the source's own label NCT07542314 ↗
Route Intravenous “Administered via an intravenous infusion.” NCT07542314 ↗