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Sarepta Therapeutics, Inc. (SRPT)

Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to the discovery and advancement of genetic treatment modalities, including RNA-targeted therapeutics and gene therapies, specifically for rare diseases. The company currently offers two approved treatments: EXONDYS 51, prescribed for Duchenne muscular dystrophy (DMD) patients with confirmed dystrophin gene mutations amenable to exon 51 skipping, and VYONDYS 53, for DMD patients with exon 53 skipping mutations. Sarepta's development pipeline includes AMONDYS 45, an exon-skipping product candidate utilizing phosphorodiamidate morpholino oligomer chemistry for exon 45; SRP-5051, a peptide-conjugated PMO designed to target exon 51 of dystrophin pre-mRNA; and gene therapy programs such as SRP-9001 for DMD and SRP-9003 for limb-girdle muscular dystrophies. The company maintains collaborative agreements with organizations like F. Hoffman-La Roche Ltd, Nationwide Children's Hospital, Lysogene, Duke University, Genethon, and StrideBio. Founded in 1980, Sarepta Therapeutics is headquartered in Cambridge, Massachusetts.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Sarepta Therapeutics, Inc. logo

Sarepta Therapeutics, Inc.

NASDAQ:SRPTHealthcare
-3.17%$18.62
AH$18.80+0.97%vs close
Mkt Cap$1.97B
Float98.21M
O/S105.63M
Vol
$ Vol
RVOL
Inst Own101.3%
SI22.7%
Earnings
Dilution
Sarepta Therapeutics, Inc. logoNASDAQ:SRPT$18.62-3.17%
Upcoming Catalysts
Phase Distribution
52 lead-sponsored trials·13 active·23 completed
Phase 120
Phase 1/210
Phase 29
Phase 39
Phase 41
Not applicable3
(7 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Recruiting

    Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting

    ELEVIDYS, Sirolimus

    Duchenne Muscular Dystrophy

    Enrollment
    20
    Start
    Oct 2026est.
    Primary Completion
    Aug 2027est.
    Completion
    Aug 2027est.
    NCT07542314
  • Phase 3
    Completed

    Study of Eteplirsen in DMD Patients

    eteplirsen

    Duchenne Muscular Dystrophy (DMD)

    Enrollment
    109
    Start
    Nov 2014
    Primary Completion
    Jun 2019
    Completion
    Jun 2019
    NCT02255552
  • Phase 3
    Completed

    Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD)

    SRP-4045, SRP-4053

    Duchenne Muscular Dystrophy

    Enrollment
    228
    Start
    Sep 2016
    Primary Completion
    Nov 2024
    Completion
    Oct 2025
    NCT02500381
  • Phase 3
    Terminated

    An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy

    Casimersen, Golodirsen

    Duchenne Muscular Dystrophy

    Enrollment
    171
    Start
    Aug 2018
    Primary Completion
    Jul 2023
    Completion
    Jul 2023
    NCT03532542
  • Phase 3
    Active, not recruiting

    A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)

    Eteplirsen

    Muscular Dystrophy, Duchenne

    Enrollment
    160
    Start
    Jul 2020
    Primary Completion
    Oct 2026est.
    Completion
    Oct 2026est.
    NCT03992430
  • Phase 3
    Completed

    A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)

    delandistrogene moxeparvovec, placebo

    Duchenne Muscular Dystrophy

    Enrollment
    126
    Start
    Oct 2021
    Primary Completion
    Oct 2023
    Completion
    Oct 2024
    NCT05096221
  • Phase 3
    Active, not recruiting

    A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)

    delandistrogene moxeparvovec, placebo

    Duchenne Muscular Dystrophy

    Enrollment
    148
    Start
    May 2023
    Primary Completion
    May 2027est.
    Completion
    Jun 2028est.
    NCT05881408
  • Phase 3
    Enrolling by invitation

    A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study

    delandistrogene moxeparvovec

    Duchenne Muscular Dystrophy

    Enrollment
    400
    Start
    Sep 2023
    Primary Completion
    Oct 2033est.
    Completion
    Oct 2033est.
    NCT05967351
  • Phase 3
    Active, not recruiting

    A Trial to Learn More About an Experimental Gene Therapy Called Bidridistrogene Xeboparvovec (SRP-9003) as a Possible Treatment for Limb Girdle Muscular Dystrophy 2E/R4

    SRP-9003, Glucocorticoid

    Limb-girdle Muscular Dystrophy

    Enrollment
    17
    Start
    Jan 2024
    Primary Completion
    Mar 2025
    Completion
    Nov 2029est.
    NCT06246513
  • Phase 3
    Withdrawn

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

    SRP-9005, Corticosteroid

    Muscular Dystrophies, Limb-Girdle

    Enrollment
    0
    Start
    Jun 2025est.
    Primary Completion
    Nov 2030est.
    Completion
    Mar 2032est.
    NCT06952686
  • Phase 2
    Completed

    Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries

    RESTEN-MP

    Coronary Artery Disease, Coronary Restenosis

    Enrollment
    50
    Start
    Sep 2005
    Primary Completion
    -
    Completion
    -
    NCT00248066
  • Phase 2
    Terminated

    Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)

    AVI-5126

    Cardiovascular Disease, Coronary Artery Bypass

    Enrollment
    600
    Start
    Mar 2007
    Primary Completion
    Nov 2007
    Completion
    Mar 2009
    NCT00451256
  • Phase 2
    Completed

    Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients

    AVI-4658 (Eteplirsen)

    Duchenne Muscular Dystrophy

    Enrollment
    12
    Start
    Jul 2011
    Primary Completion
    Feb 2012
    Completion
    Jun 2012
    NCT01396239
  • Phase 2
    Completed

    Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy

    AVI-4658 (Eteplirsen)

    Duchenne Muscular Dystrophy (DMD)

    Enrollment
    12
    Start
    Feb 2012
    Primary Completion
    Apr 2016
    Completion
    Aug 2017
    NCT01540409
  • Phase 2
    Completed

    Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular Dystrophy

    Eteplirsen

    Muscular Dystrophy, Duchenne

    Enrollment
    24
    Start
    Nov 2014
    Primary Completion
    Apr 2017
    Completion
    Mar 2018
    NCT02286947
  • Phase 2
    Completed

    Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular Dystrophy

    eteplirsen

    Duchenne Muscular Dystrophy (DMD)

    Enrollment
    33
    Start
    Jun 2015
    Primary Completion
    Dec 2018
    Completion
    Dec 2018
    NCT02420379
  • Phase 2
    Completed

    Study of Eteplirsen in Young Participants With Duchenne Muscular Dystrophy (DMD) Amenable to Exon 51 Skipping

    Eteplirsen

    Duchenne Muscular Dystrophy

    Enrollment
    15
    Start
    Aug 2017
    Primary Completion
    Mar 2021
    Completion
    Mar 2021
    NCT03218995
  • Phase 2
    Terminated

    A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)

    Eteplirsen

    Duchenne Muscular Dystrophy

    Enrollment
    15
    Start
    Jun 2019
    Primary Completion
    Aug 2022
    Completion
    Aug 2022
    NCT03985878
  • Phase 2
    Terminated

    Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Expansion (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment

    Vesleteplirsen

    Duchenne Muscular Dystrophy

    Enrollment
    62
    Start
    Jun 2019
    Primary Completion
    Oct 2023
    Completion
    Feb 2025
    NCT04004065
  • Phase 1/2
    Terminated

    Study of AVI-4065 in Healthy Volunteers and Chronic Active HCV Patients

    AVI-4065 Injection

    Hepatitis C

    Enrollment
    80
    Start
    Sep 2005
    Primary Completion
    Oct 2006
    Completion
    Jan 2007
    NCT00229749
  • Phase 1/2
    Completed

    Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients

    AVI-4658 for Injection

    Duchenne Muscular Dystrophy

    Enrollment
    19
    Start
    Jan 2009
    Primary Completion
    Jun 2010
    Completion
    Dec 2010
    NCT00844597
  • Phase 1/2
    Completed

    A Gene Transfer Therapy Study to Evaluate the Safety of SRP-9004 (Patidistrogene Bexoparvovec) in Participants With Limb-Girdle Muscular Dystrophy, Type 2D (LGMD2D)

    SRP-9004

    Limb-Girdle Muscular Dystrophy, Type 2D

    Enrollment
    6
    Start
    Feb 2015
    Primary Completion
    Mar 2019
    Completion
    Mar 2019
    NCT01976091
  • Phase 1/2
    Completed

    Phase I/II Study of SRP-4053 in DMD Patients

    Placebo, SRP-4053

    Duchenne Muscular Dystrophy

    Enrollment
    39
    Start
    Jan 2015
    Primary Completion
    Mar 2019
    Completion
    Mar 2019
    NCT02310906
  • Phase 1/2
    Completed

    A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)

    delandistrogene moxeparvovec

    Duchenne Muscular Dystrophy

    Enrollment
    4
    Start
    Jan 2018
    Primary Completion
    Apr 2023
    Completion
    Apr 2023
    NCT03375164
  • Phase 1/2
    Terminated

    Gene Delivery Clinical Trial of SRP-9003 (Bidridistrogene Xeboparvovec) for Participants With Limb-Girdle Muscular Dystrophy, Type 2E (LGMD2E) (Beta-Sarcoglycan Deficiency)

    SRP-9003

    Limb-Girdle Muscular Dystrophy, Type 2E

    Enrollment
    6
    Start
    Oct 2018
    Primary Completion
    Jan 2025
    Completion
    Jan 2025
    NCT03652259

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