Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Sarepta Therapeutics Inc.

www.sarepta.com

Latest From Sarepta Therapeutics Inc.

With Sarepta’s Vyondys, US FDA Staff Saw Opportunity To Right Perceived Wrongs With Exondys

ODE I director Ellis Unger chafed at the notion of approving the Duchenne muscular dystrophy drug golodirsen on the same unvalidated surrogate marker, this time in the face of infection and renal toxicity concerns; OND’s Peter Stein granted Sarepta’s appeal while also calling attention to the company’s failure to timely conduct the eteplirsen confirmatory trial.

Drug Review Profile Rare Diseases

A Tale Of Two DMD Drugs: Theme And Variation In Controversial US FDA Reviews

Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.

Rare Diseases Approvals

Neuroscience Challenges Oncology For Top Spot In CDER’s 2019 Novel Approvals

Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.

Review Pathway Pink Sheet Perspectives

Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues

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

US FDA Performance Tracker Drug Review
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, EVP, Chief Commercial Officer
    Gilmore O'Neill, SVP, R&D & CMO
    Gary Charbonneau, SVP, Reg. Affairs
  • Contact Info
  • Sarepta Therapeutics Inc.
    Phone: (617) 274-4000
    215 First St.
    Cambridge, MA 02142
    USA
UsernamePublicRestriction

Register