Codiak BioSciences (Sarepta)
Cambridge, MA
Hybrid — also manufactures internal programs
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
78.0
Signal Score
✓ FDA Inspections (1)
✓ Clinical Trials (16)
✓ SEC Filings (13)
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: Codiak BioSciences (Sarepta)
- Signal Score
- 78.0/100 (as of 2026-09-07)
- Quality Compliance
- 100.0/100
- Headquarters
- Cambridge, MA
- Modalities
- Exosome
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Codiak BioSciences (Sarepta)
Hybrid developer + CDMO.
Signal Score & Pillar Breakdown
Scores are being republished.
Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance
100.0
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-07-15)
Operations
60.0
Programs
— no verified data
Sponsors— no verified data
ModalitiesExosome
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
NCT06270719
An Observational Study Comparing Delandistrogene Moxeparvovec...
NA
Enrolling By Invitation
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
NCT05876780
A Gene Transfer Single Dose Study to Evaluate the Safety,...
PHASE1
Active Not Recruiting
View all 16 programs →
Source: ClinicalTrials.gov · Retrieved Oct 07, 2026
Financial Stability
74.0
13 SEC filings with industry mentions on record
SEC Filings13 with industry mentions
Capacity
66.0
Profile-based capacity assessment
Codiak BioSciences (Sarepta) FDA Inspection History
2025-07
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-07-15 |
Sarepta Therapeutics Inc
Andover, Massachusetts
Facility-linked
|
Human Cellular, Tissue, and Gene Therapies | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 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 (ELEVIDYS)...
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 Oct 07, 2026
Financial Intelligence
"These forward-looking statements include, but are not limited to:
•
our belief that our proprietary technology, technology platforms and collaborations can be used to develop potential therapeutic candidates to treat a broad range of diseases, including the diseases that we are targeting;
•
our expectation that our partnerships with manufacturers will support our clinical and commercial manufacturing capacity for our products and product candidates, including our posphorodiamidate morpholino oli"
"Food and Drug Administration (the “FDA") has placed on our investigational use gene therapy clinical trials for Limb-girdle muscular dystrophy ("LGMD") in July 2025 and the revocation of the platform technology designation for our AAVrh74 platform technology previously granted on June 2, 2025;
•
the possible impacts of the results of our ESSENCE confirmatory trial for VYONDYS 53 and AMONDYS 45, including the timing and outcome of any additional results, potential regulatory actions from the FDA,"
"(“Catalent”) will support our clinical and commercial manufacturing demand for certain of our programs, while also acting as a manufacturing platform for potential future gene therapy programs;
•
our expectation that Aldevron LLC (“Aldevron”) will provide Good Manufacturing Processes (“GMP”)-grade plasmid for our current and any future gene therapy programs;
•
the possible impacts of the ELEVIDYS Suspension (as defined below);
•
the possible impact of regulations and regulatory decisions by the "
"(together with its wholly-owned subsidiaries, “Sarepta” or the “Company”) is a commercial-stage biopharmaceutical company focused on helping patients through the discovery and development of unique RNA-targeted therapeutics, small interfering RNA ("siRNA") platform, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases."
"ELEVIDYS (delandistrogene moxeparvovec-rokl), an adeno-associated virus-(“AAV”) based gene therapy, was approved by the FDA in June 2024 for the treatment of ambulatory patients at least four years old with Duchenne with a confirmed mutation in the Duchenne gene, as well as for non-ambulatory patients under the accelerated approval pathway."
"In June 2025, the Company received a milestone payment of $
63.5
million in connection with the receipt of regulatory approval of ELEVIDYS in Japan for individuals ages 3- to less than 8-years-old, who do not have any deletions in exon 8 and/or exon 9 in the Duchenne gene and who are negative for anti-AAVrh74 antibodies."
"(together with its wholly-owned subsidiaries, “Sarepta” or the “Company”) is a commercial-stage biopharmaceutical company focused on helping patients through the discovery and development of unique RNA-targeted therapeutics, small interfering RNA ("siRNA") platform, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases."
"ELEVIDYS (delandistrogene moxeparvovec-rokl), an adeno-associated virus-(“AAV”) based gene therapy, was approved by the FDA on June 20, 2024 for the treatment of ambulatory patients at least four years old with Duchenne with a confirmed mutation in the Duchenne gene, as well as for non-ambulatory patients under the accelerated approval pathway."
"In June 2025, the Company received a milestone payment of $
63.5
million in connection with the receipt of regulatory approval of ELEVIDYS in Japan for individuals ages 3- to less than 8-years-old, who do not have any deletions in exon 8 and/or exon 9 in the Duchenne gene and who are negative for anti-AAVrh74 antibodies."
"(together with its wholly-owned subsidiaries, “Sarepta” or the “Company”) is a commercial-stage biopharmaceutical company focused on helping patients through the discovery and development of unique RNA-targeted therapeutics, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases."
"ELEVIDYS (delandistrogene moxeparvovec-rokl), an adeno-associated virus-(“AAV”) based gene therapy, was approved by the FDA on June 20, 2024 for the treatment of ambulatory patients at least four years old with Duchenne with a confirmed mutation in the Duchenne gene, as well as for non-ambulatory patients under the accelerated approval pathway."
"Contract manufacturing revenue and royalty revenue are included in collaboration and other revenues in the unaudited condensed consolidated statements of comprehensive (loss) income."
"•
our expectation that our partnerships with manufacturers will support our clinical and commercial manufacturing capacity for our Duchenne muscular dystrophy (“Duchenne”) gene therapy program and Limb-girdle muscular dystrophy (“LGMD”) programs, while also acting as a manufacturing platform for potential future gene therapy programs, and our belief that our current network of manufacturing partners is able to fulfill the requirements of our commercial plan;"
"(“Catalent”) will support our clinical and commercial manufacturing demand for our Duchenne gene therapy program and LGMD programs, while also acting as a manufacturing platform for potential future gene therapy programs;"
"•
our expectation that Aldevron LLC (“Aldevron”) will provide Good Manufacturing Processes (“GMP”)-grade plasmid for our Duchenne gene therapy program and LGMD programs, as well as plasmid source material for future gene therapy programs;"
"(together with its wholly-owned subsidiaries, “Sarepta” or the “Company”) is a commercial-stage biopharmaceutical company focused on helping patients through the discovery and development of unique RNA-targeted therapeutics, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases."
"ELEVIDYS (delandistrogene moxeparvovec-rokl), approved by the FDA on June 20, 2024, is an adeno-associated virus-(“AAV”) based gene therapy for the treatment of ambulatory patients at least four years old with Duchenne with a confirmed mutation in the Duchenne gene."
"Contract manufacturing revenue and royalty revenue are included in collaboration and other revenue in the accompanying unaudited condensed consolidated statements of comprehensive income (loss)."
"(together with its wholly-owned subsidiaries, “Sarepta” or the “Company”) is a commercial-stage biopharmaceutical company focused on helping patients through the discovery and development of unique RNA-targeted therapeutics, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases."
"ELEVIDYS (delandistrogene moxeparvovec-rokl), approved by the FDA on June 20, 2024, is an adeno-associated virus-based gene therapy for the treatment of ambulatory pediatric patients at least 4 years old with Duchenne with a confirmed mutation in the Duchenne gene."
"For the six months ended June 30, 2024, the Company recognized $
5.8
million of contract manufacturing revenue related to these shipments, with
no
similar activity for the
six months ended June 30, 2023."
"(together with its wholly-owned subsidiaries, “Sarepta” or the “Company”) is a commercial-stage biopharmaceutical company focused on helping patients through the discovery and development of unique RNA-targeted therapeutics, gene therapy and other genetic therapeutic modalities for the treatment of rare diseases."
"For the three months ended March 31, 2024, the Company recognized $
5.8
million of contract manufacturing revenue related to these shipments, with
no
similar activity for the
three months ended March 31, 2023."
"Accrued contract manufacturing costs"
Source: SEC EDGAR · Retrieved Oct 07, 2026
Frequently Asked Questions About Codiak BioSciences (Sarepta)
How many FDA inspections does Codiak BioSciences (Sarepta) have on record?
CDMO Signal tracks 1 FDA inspection for Codiak BioSciences (Sarepta), sourced from the FDA inspection database. See the full inspection history above.
Has Codiak BioSciences (Sarepta) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Codiak BioSciences (Sarepta).
How many clinical programs is Codiak BioSciences (Sarepta) linked to?
Codiak BioSciences (Sarepta) is associated with 16 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Codiak BioSciences (Sarepta)'s CDMO Signal Score?
Codiak BioSciences (Sarepta) has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
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