Codiak BioSciences (Sarepta)

Cambridge, MA
Hybrid — also manufactures internal programs
Exosome
16 confirmed programs · 2 sponsors · Last scored 2026-03-15
60.5
Signal Score
✓ FDA Inspections (1) ✓ Clinical Trials (16) ○ SEC Filings ○ Press

Quick Facts: Codiak BioSciences (Sarepta)

Signal Score
60.5/100 (as of 2026-03-15)
Quality Compliance
Assessment pending
Headquarters
Cambridge, MA
Modalities
Exosome
Active CGT Programs
16 confirmed from ClinicalTrials.gov across 2 sponsors
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CGT manufacturing intelligence platform

Signal Score & Pillar Breakdown

Quality Compliance —
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-07-15)
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs 16
Sponsors2
ModalitiesExosome
16 active programs across 2 sponsors
Modalities: Exosome
8 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT06952686 A Study of SRP-9005 in Limb Girdle Muscular Dystrophy Type... PHASE3 Withdrawn
NCT06747273 Study to Evaluate the Safety, Tolerability, and Efficacy of... PHASE1 Terminated
NCT06597656 A Gene Transfer Therapy to Evaluate the Safety and Efficacy... PHASE1 Terminated
NCT06270719 An Observational Study Comparing Delandistrogene Moxeparvovec... NA Enrolling By Invitation
NCT06241950 A Gene Transfer Therapy Study to Evaluate the Safety and... PHASE1 Terminated
NCT06246513 A Trial to Learn More About an Experimental Gene Therapy... PHASE3 Active Not Recruiting
NCT05881408 A Gene Transfer Therapy Study to Evaluate the Safety and... PHASE3 Active Not Recruiting
NCT05906251 A Gene Transfer Study to Evaluate the Safety, Tolerability... PHASE1 Terminated
NCT05876780 A Gene Transfer Single Dose Study to Evaluate the Safety,... PHASE1 Active Not Recruiting
NCT05096221 A Gene Transfer Therapy Study to Evaluate the Safety and... PHASE3 Completed
View all 16 programs →
Source: ClinicalTrials.gov · Retrieved Mar 20, 2026
Financial Stability 68.0
Parent company: Sarepta Therapeutics
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Subsidiary of Sarepta Therapeutics
SEC FilingsParent: Sarepta Therapeutics
Parent company: Sarepta Therapeutics
Financial assessment: 68.0/100
Capacity 53.0
1 CGT manufacturing site: Cambridge, MA
Modalities: Exosome
Capacity assessment: 53.0/100
Sites: Cambridge, MA
Source: SEC EDGAR, press monitoring, company profiles
1 CGT manufacturing site
1 CGT manufacturing site: Cambridge, MA
Modalities: Exosome
Capacity assessment: 53.0/100

FDA Inspection History

2025-07
NAI VAI OAI
Date Site Type Observations Classification
2025-07-15 Andover, Massachusetts Human Cellular, Tissue, and Gene Therapies No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved Mar 20, 2026

Clinical Activity 16 studies

NCT06952686 A Study of SRP-9005 in Limb Girdle Muscular Dystrophy Type 2C/R5 Pediatric... PHASE3 Withdrawn NCT06747273 Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9004... PHASE1 Terminated NCT06597656 A Gene Transfer Therapy to Evaluate the Safety and Efficacy of... PHASE1 Terminated NCT06270719 An Observational Study Comparing Delandistrogene Moxeparvovec With Standard... NA Enrolling By Invitation NCT06241950 A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of... PHASE1 Terminated NCT06246513 A Trial to Learn More About an Experimental Gene Therapy Called... PHASE3 Active Not Recruiting NCT05881408 A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of... PHASE3 Active Not Recruiting NCT05906251 A Gene Transfer Study to Evaluate the Safety, Tolerability and Efficacy of... PHASE1 Terminated NCT05876780 A Gene Transfer Single Dose Study to Evaluate the Safety, Tolerability and... PHASE1 Active Not Recruiting NCT05096221 A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of... PHASE3 Completed NCT04626674 A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From... PHASE1 Recruiting NCT04179409 A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of AMONDYS... PHASE2 Completed NCT03652259 Gene Delivery Clinical Trial of SRP-9003 (Bidridistrogene Xeboparvovec) for... PHASE1/PHASE2 Terminated NCT03375164 A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene... PHASE1/PHASE2 Completed NCT02710500 rAAVrh74.MHCK7.DYSF.DV for Treatment of Dysferlinopathies PHASE1 Completed NCT01976091 A Gene Transfer Therapy Study to Evaluate the Safety of SRP-9004... PHASE1/PHASE2 Completed
Source: ClinicalTrials.gov · Retrieved Mar 20, 2026
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