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Sarepta Therapeutics

Sarepta Therapeutics logo
🇺🇸United States
Ownership
Private, Public
Established
1980-01-01
Employees
1.3K
Market Cap
$13.4B
Website
http://www.sarepta.com
Introduction

Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which is engaged in the discovery and development of therapeutics for the treatment of rare diseases. The company was founded on July 22, 1980, and is headquartered in Cambridge, MA.

Clinical Trials

123

Active:75
Completed:22

Trial Phases

3 Phases

Phase 1:92
Phase 2:10
Phase 3:15

Drug Approvals

4

FDA:4

Drug Approvals

Vyondys 53

Approval Date
Mar 13, 2025
FDA

ELEVIDYS

Approval Date
Oct 11, 2023
FDA

AMONDYS 45

Approval Date
Mar 23, 2023
FDA

Exondys 51

Approval Date
Mar 14, 2022
FDA

Clinical Trials

Distribution across different clinical trial phases (117 trials with phase data)• Click on a phase to view related trials

Phase 1
92 (78.6%)
Phase 3
15 (12.8%)
Phase 2
10 (8.5%)

A Study of SRP-9005 in Limb Girdle Muscular Dystrophy Type 2C/R5 Pediatric and Adult Participants

Phase 3
Withdrawn
Conditions
Muscular Dystrophies, Limb-Girdle
Interventions
Drug: Corticosteroid
First Posted Date
2025-05-01
Last Posted Date
2025-08-06
Lead Sponsor
Sarepta Therapeutics, Inc.
Target Recruit Count
15
Registration Number
NCT06952686
Locations
🇺🇸

Children's Hospital of the King's Daughters, Norfolk, Virginia, United States

Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9004 Administered by Systemic Infusion in Limb Girdle Muscular Dystrophy Type 2D/R3 Participants in the United States

Phase 1
Active, not recruiting
Conditions
Limb Girdle Muscular Dystrophy
Limb Girdle Muscular Dystrophy Type 2D/R3
Interventions
First Posted Date
2024-12-24
Last Posted Date
2025-04-27
Lead Sponsor
Sarepta Therapeutics, Inc.
Target Recruit Count
4
Registration Number
NCT06747273
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

Children's Hospital of the King's Daughters, Norfolk, Virginia, United States

A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical Practice

Conditions
Duchenne Muscular Dystrophy
Interventions
First Posted Date
2024-09-23
Last Posted Date
2024-09-23
Lead Sponsor
Sarepta Therapeutics, Inc.
Target Recruit Count
300
Registration Number
NCT06606340
Locations
🇺🇸

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, United States

🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

University of California Davis Medical Center, Sacramento, California, United States

and more 17 locations

A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74

Phase 1
Recruiting
Conditions
Duchenne Muscular Dystrophy
First Posted Date
2024-09-19
Last Posted Date
2025-07-14
Lead Sponsor
Sarepta Therapeutics, Inc.
Target Recruit Count
10
Registration Number
NCT06597656
Locations
🇺🇸

University of Florida, College of Medicine, Gainesville, Florida, United States

🇺🇸

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy

Conditions
Duchenne Muscular Dystrophy
Interventions
Genetic: Delandistrogene Moxeparvovec
Drug: Standard of Care
First Posted Date
2024-02-21
Last Posted Date
2025-08-11
Lead Sponsor
Sarepta Therapeutics, Inc.
Target Recruit Count
500
Registration Number
NCT06270719
Locations
🇺🇸

All Children's Research Institute, Inc, Saint Petersburg, Florida, United States

🇺🇸

OHSU Healthcare (Oregon Health and Science University), Portland, Oregon, United States

🇺🇸

Arkansas Children's Hospital, Little Rock, Arkansas, United States

and more 16 locations
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News

Schrödinger Discontinues Blood Cancer Drug SGR-2921 After Two Patient Deaths in Phase I Trial

Schrödinger has terminated development of its CDC7 inhibitor SGR-2921 after two patient deaths in a Phase I trial for relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndromes.

FDA Official Dr. Vinay Prasad Resigns After Three Months Amid Sarepta Gene Therapy Controversy

Dr. Vinay Prasad resigned from his FDA leadership position after less than three months following criticism from right-wing activists and pressure from the White House.

Arrowhead Pharmaceuticals Receives $100 Million Milestone Payment for ARO-DM1 Myotonic Dystrophy Treatment

Arrowhead Pharmaceuticals earned a $100 million milestone payment from Sarepta Therapeutics after reaching enrollment targets for ARO-DM1, an RNAi therapeutic for type 1 myotonic dystrophy.

FDA Appoints Biotech Veteran George Tidmarsh to Lead Drug Regulation Center Amid Agency Restructuring

The FDA has appointed Dr. George Tidmarsh, a former pharmaceutical executive and cancer specialist, to direct the Center for Drug Evaluation and Research, the agency's largest division responsible for reviewing drug safety and effectiveness.

Sarepta Therapeutics Implements $400 Million Cost-Cutting Plan Amid Regulatory Challenges for Gene Therapy

Sarepta Therapeutics announced a $400 million annual cost-savings initiative in July 2025, including a 36% workforce reduction of 500 employees to achieve financial sustainability through 2027.

CNS Oligonucleotide Licensing Deals Surge 339% to $2.81 Billion in 2024

Licensing agreements for CNS-targeted oligonucleotide therapeutics increased 339% from 2023 to 2024, reaching $2.81 billion in total deal value according to GlobalData's analysis.

FDA Awards Sarepta First Platform Technology Designation for Gene Therapy Vector

The FDA has granted Sarepta Therapeutics a platform technology designation for its rAAVrh74 viral vector, marking one of the first such awards since the program launched in 2024.

FDA Places Clinical Hold on Rocket Pharmaceuticals' Danon Disease Gene Therapy After Patient Death

The FDA has placed a clinical hold on Rocket Pharmaceuticals' Phase II gene therapy trial for RP-A501 after a patient developed capillary leak syndrome and subsequently died.

Satellos Reports Promising Efficacy Signals for Novel DMD Treatment in Adult Patients

Satellos Bioscience's investigational treatment for Duchenne muscular dystrophy (DMD) has demonstrated encouraging efficacy signals in adult patients, offering potential new options in a challenging therapeutic area.

Sarepta Therapeutics Revises 2025 Guidance Following ELEVIDYS Safety Event and Operational Challenges

Sarepta Therapeutics reported strong Q1 2025 revenue of $744.9 million, beating analyst estimates by 7.4% with 80.2% year-over-year growth driven by increased ELEVIDYS usage.

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