---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-029354"
form_type: "8-K"
ticker: "SRPT"
cik: "0000873303"
company_name: "Sarepta Therapeutics, Inc."
filed_at: "2023-06-22T23:59:59+00:00"
generated_at: "2026-06-13T19:34:01.267585+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# FDA grants accelerated approval for Sarepta's ELEVIDYS gene therapy for Duchenne MD

## Summary
- First FDA-approved gene therapy for Duchenne muscular dystrophy; for ambulatory patients aged 4-5.
- Accelerated approval based on micro-dystrophin expression; confirmatory trial EMBARK reads out late 2023.
- Contraindicated in patients with deletions in exon 8 and/or 9 of the DMD gene.
- Common adverse reactions include vomiting, nausea, liver enzyme increases, pyrexia, thrombocytopenia.

## SEC filing metadata
- accession: 0000950170-23-029354
- form_type: 8-K
- ticker: SRPT
- cik: 0000873303
- company_name: Sarepta Therapeutics, Inc.
- filed_at: 2023-06-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/873303/000095017023029354/0000950170-23-029354-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/873303/000095017023029354/srpt-20230622.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-029354
- JSON: https://secwatch.observer/filing/0000950170-23-029354.json
- Plain text: https://secwatch.observer/filing/0000950170-23-029354.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.