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Sarepta Therapeutics Inc.

www.sarepta.com

Latest From Sarepta Therapeutics Inc.

Golodirsen Rebuff: Did Exondys 51 Review Strife Influence US FDA's Decision?

Sarepta cited two safety issues when announcing a complete response letter for its exon 53 skipping DMD drug golodirsen, but the US FDA's decision may be a result of the Exondys 51 approval from 2016, analysts suggest.
Complete Response Letters Drug Review

Sarepta Surprised By CRL For Exon 53-Skipping DMD Drug Golodirsen

The US FDA issued a complete response letter rejecting golodirsen based on risk of infection at intravenous infusion ports and preclinical renal toxicity.

Complete Response Letters Drug Safety

ICER Reviews Duchenne: Exondys 51 Lacks Net Health Benefit; Emflaza Fairs Better

High price tag, thin evidence of clinical efficacy for Exondys 51 result in low score from ICER, but a re-do is almost certain when confirmatory data on eteplirsen are released.

Reimbursement Neurology

Made In China Gene Therapy A Father's Quest To Save Son With UltraRare Condition

Patient-driven drug development meets the old saying of "where there's a will, there's a way" in China, potentially the world's largest market for rare disease treatments.

Gene Therapy Innovation
See All

Company Information

  • Industry
  • Biotechnology
    • Antisense, Oligonucleotides
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Pharmaceuticals
    • Vaccines
  • Therapeutic Areas
  • Infectious & Viral Diseases
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Alias(es)
  • AVI BioPharma Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Sarepta Therapeutics Inc.
  • Senior Management
  • Douglas Ingram, Pres. & CEO
    Sandesh Mahatme, EVP, CFO & CBO
    Bo Cumbo, SVP, Chief Commercial Officer
    Gilmore O'Neill, SVP, R&D & CMO
  • Contact Info
  • Sarepta Therapeutics Inc.
    Phone: (617) 274-4000
    215 First St.
    Cambridge, MA 02142
    USA
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