Bristol Myers Squibb (CGT Mfg)
Bothell, WA · Warren, NJ
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
91.1
Signal Score
✓ FDA Inspections (6)
✓ Clinical Trials (586)
✓ SEC Filings (15)
○ Press
✓ EMA GMP (1)
✓ MHRA GMP (1)
Quick Facts: Bristol Myers Squibb (CGT Mfg)
- Signal Score
- 91.1/100 (as of 2026-09-07)
- Quality Compliance
- 97.9/100
- Headquarters
- Bothell, WA · Warren, NJ
- Modalities
- CAR-T, Cell Therapy
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Bristol Myers Squibb (CGT Mfg)
Manufactures Breyanzi and Abecma CAR-T therapies.
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
97.9
FDA Inspections6 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2026-04-28)
EMA GMP Certificates1 on record
MHRA GMP Certificates1 on record
Operations
95.2
Programs
— no verified data
Sponsors— no verified data
ModalitiesCAR-T, Cell Therapy
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
NCT07680790
Study of Izalontamab Brengitecan (BMS-986507) in Combination...
PHASE3
Not Yet Recruiting
NCT07573332
A Safety and Tolerability Study of CC- 97540 (BMS-086353) in...
PHASE1
Not Yet Recruiting
NCT07727668
Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior...
EARLY_PHASE1
Not Yet Recruiting
NCT07388277
CC-97540 in Patients With Antineutrophil Cytoplasmic...
PHASE1/PHASE2
Active Not Recruiting
View all 586 programs →
Source: ClinicalTrials.gov · Retrieved Oct 06, 2026
Financial Stability
89.0
15 SEC filings with industry mentions on record
SEC Filings15 with industry mentions
Capacity
76.0
Profile-based capacity assessment
Bristol Myers Squibb (CGT Mfg) FDA Inspection History
2026-04
2025-07
2025-07
2024-12
2024-09
2024-09
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-04-28 |
Bristol Myers Squibb
Princeton, New Jersey
Facility-linked
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2025-07-18 |
Celgene Corporation
Summit, New Jersey
Facility-linked
|
Human Cellular, Tissue, and Gene Therapies | No | Voluntary Action Indicated (VAI) |
| 2025-07-08 |
Bristol-Myers Squibb Company
Devens, Massachusetts
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-12-06 |
Celgene Corporation
Summit, New Jersey
Facility-linked
|
Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
| 2024-09-24 |
Juno Therapeutics, Inc.
Bothell, Washington
Facility-linked
|
Human Cellular, Tissue, and Gene Therapies | No | No Action Indicated (NAI) |
| 2024-09-06 |
Celgene Corporation
Summit, New Jersey
Facility-linked
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Oct 06, 2026
Bristol Myers Squibb (CGT Mfg) EMA GMP Compliance 1 certificates
2026-02
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| CRN00GYR3/IMP13128/00001 | Bristol-Myers Squibb Services Unlimited Company | Ireland | 2026-02-10 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 06, 2026
Bristol Myers Squibb (CGT Mfg) MHRA GMP Compliance 1 certificates
2014-08
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 14758 Insp GMP 14758/5575-0003[H] | CELGENE CORPORATION | 07901 | 2014-08-21 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Oct 06, 2026
Clinical Activity 586 studies
NCT07711483
GLORY: Glofit-GemOx With Liso-Cel For Lymphoma
PHASE2
Not Yet Recruiting
NCT07680790
Study of Izalontamab Brengitecan (BMS-986507) in Combination With...
PHASE3
Not Yet Recruiting
NCT07573332
A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin...
PHASE1
Not Yet Recruiting
NCT07335562
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene-...
PHASE3
Not Yet Recruiting
NCT07624513
D2 - Isa-Iber-VD Induction, Followed by Risk & Response Adapted...
PHASE3
Not Yet Recruiting
NCT07680764
A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in...
PHASE2
Recruiting
NCT07620574
Long-Term Extension Study for Participants Previously Enrolled in an...
PHASE3
Enrolling By Invitation
NCT07727668
Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis...
EARLY_PHASE1
Not Yet Recruiting
NCT07544589
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced...
PHASE1
Recruiting
NCT07388277
CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
PHASE1/PHASE2
Active Not Recruiting
NCT07777120
Liso-Cel in Relapsed/Refractory Marginal Zone Lymphoma
NA
Active Not Recruiting
NCT07361497
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent...
PHASE3
Recruiting
NCT07361510
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in...
PHASE3
Recruiting
NCT07333261
Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
PHASE1
Recruiting
NCT07325136
A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in...
PHASE1/PHASE2
Recruiting
NCT07465029
A Study of Incidence, Treatment Patterns, and Outcomes in...
NA
Active Not Recruiting
NCT07526961
Real-World Outcomes of First-Line Nivolumab + Ipilimumab With Chemotherapy...
NA
Completed
NCT07100080
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for...
PHASE2/PHASE3
Recruiting
NCT06855771
A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated...
PHASE2
Recruiting
NCT07018752
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral...
PHASE1/PHASE2
Recruiting
+ 566 more studies
Source: ClinicalTrials.gov · Retrieved Oct 06, 2026
Financial Intelligence
"Our platforms are comprised of chemically-synthesized or small molecule drugs including protein degraders, drugs produced from biological processes, called “biologics”, ADCs, CAR-T cell therapies, and radiopharmaceutical therapeutics."
"CAR-T cell therapies are administered by intravenous infusion."
"Breyanzi
®
Breyanzi
(lisocabtagene maraleucel) is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory LBCL after one or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, grade 3B FL and relapsed or refractory FL after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL; relapsed or refractory MCL in patie"
"The acquisition will provide BMS with full rights to OTX-201, a preclinical
in vivo
CAR T-cell therapy currently in IND-enabling studies for autoimmune disease."
"rights to
Abecma
, a cell therapy for the treatment of adult patients with relapsed or refractory multiple myeloma."
"In October 2025, BMS entered into a definitive agreement to acquire Orbital Therapeutics, which will provide the Company with full rights to OTX-201, a preclinical
in vivo
CAR T-cell therapy currently in IND-enabling studies for autoimmune disease."
"rights to
Abecma
, a cell therapy for the treatment of adult patients with relapsed or refractory multiple myeloma."
"Breyanzi
(lisocabtagene maraleucel) — a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory LBCL after one or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, grade 3B FL and relapsed or refractory FL after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL, and relapsed or refractory MCL in patients who "
"Abecma
(idecabtagene vicleucel) — is a BCMA genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody."
"rights to
Abecma
, a cell therapy for the treatment of adult patients with relapsed or refractory multiple myeloma."
"Breyanzi
(lisocabtagene maraleucel) — a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory LBCL after one or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, grade 3B FL and relapsed or refractory FL after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL, and relapsed or refractory MCL in patients who "
"revenues increased 133% during the first quarter of 2025 primarily due to higher demand enabled by expanded manufacturing capacity, new indication launches and higher average net selling prices."
"Our platforms are comprised of chemically-synthesized or small molecule drugs including protein degraders; drugs produced from biological processes, called “biologics”; ADCs, CAR-T cell therapies, and radiopharmaceutical therapeutics."
"CAR-T cell therapies are administered by intravenous infusion."
"2
Breyanzi
®
Breyanzi
(lisocabtagene maraleucel) is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory LBCL after one or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, grade 3B FL and relapsed or refractory FL after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL, and relapsed or refractory MCL in"
"These changes primarily include (i) transforming R&D operations to accelerate pipeline delivery, (ii) enhancing our commercial operating model, and (iii) establishing a more responsive manufacturing network and expanding our cell therapy manufacturing capabilities."
"Our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases in the following core therapeutic areas: oncology and hematology with novel modalities in cell therapies, protein degraders, ADCs and radiopharmaceuticals; immunology with a focus on establishing new standards of care in pulmonology, rapidly advancing cell therapy into immunology diseases and transformational programs to control inflammation, reset immune memory and promote homeo"
"In addition, year-to-date, we have achieved significant advances in CAR-T cell therapy with the approval of
Breyanzi
in the U.S."
"These changes primarily include (i) transforming R&D operations to accelerate pipeline delivery, (ii) enhancing our commercial operating model, and (iii) establishing a more responsive manufacturing network and expanding our cell therapy manufacturing capabilities."
"Our focus is on discovering, developing and delivering transformational medicines for patients facing serious diseases in the following five core therapeutic areas: (i) oncology with a priority in certain tumor types, including diversification beyond IO; (ii) hematology with opportunities to expand leadership position in multiple myeloma, as well as broaden our portfolio across leukemias, lymphomas and non-malignant hematologic diseases; (iii) immunology with a focus in dermatology, rheumatology"
"In 2024, we achieved significant advances in CAR-T cell therapy with the approval of
Breyanzi
in the U.S."
"These changes primarily include (i) transforming R&D operations to accelerate pipeline delivery (ii) enhancing our commercial operating model, and (iii) establishing a more responsive manufacturing network and expanding our cell therapy manufacturing capabilities."
"Our focus is on discovering, developing and delivering transformational medicines for patients facing serious diseases in the following five core therapeutic areas: (i) oncology with a priority in certain tumor types, including diversification beyond IO; (ii) hematology with opportunities to expand leadership position in multiple myeloma, as well as broaden our portfolio across leukemias, lymphomas and non-malignant hematologic diseases; (iii) immunology with a focus in dermatology, rheumatology"
"In 2024, we achieved significant advances in the CAR-T cell therapy arena with the approval of
Abecma
in the U.S."
Source: SEC EDGAR · Retrieved Oct 06, 2026
Frequently Asked Questions About Bristol Myers Squibb (CGT Mfg)
How many FDA inspections does Bristol Myers Squibb (CGT Mfg) have on record?
CDMO Signal tracks 6 FDA inspections for Bristol Myers Squibb (CGT Mfg), sourced from the FDA inspection database. See the full inspection history above.
Has Bristol Myers Squibb (CGT Mfg) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Bristol Myers Squibb (CGT Mfg).
Does Bristol Myers Squibb (CGT Mfg) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 EMA and 1 MHRA GMP certificates for Bristol Myers Squibb (CGT Mfg).
How many clinical programs is Bristol Myers Squibb (CGT Mfg) linked to?
Bristol Myers Squibb (CGT Mfg) is associated with 586 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Bristol Myers Squibb (CGT Mfg)'s CDMO Signal Score?
Bristol Myers Squibb (CGT Mfg) has a Signal Score of 91/100, based on quality, operations, financial stability, and capacity data.
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