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Sarepta Therapeutics Inc.

www.sarepta.com

Latest From Sarepta Therapeutics Inc.

Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen

The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Performance Tracker Approvals

Pink Sheet Podcast: Golodirsen CRL, Trump's Appeal Of DTC Ad Ruling, Pharmas' Statement Of Purpose'

Pink Sheet reporters discuss a Duchenne muscular dystrophy drug's denial by US FDA, the administration's attempt to revive the DTC price disclosure rule, and the Business Roundtable's new principles on corporate values.
Complete Response Letters Pricing Debate

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
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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