Novartis
Basel, Switzerland
413 confirmed programs
· 116 sponsors
· Last scored 2026-03-04
80.0
Signal Score
✓ FDA Inspections (8)
✓ Clinical Trials (135)
✓ SEC Filings (28)
✓ Press (20)
Quick Facts: Novartis
- Signal Score
- 80.0/100 (as of 2026-03-04)
- Quality Compliance
- Assessment pending
- Headquarters
- Basel, Switzerland
- Modalities
- CAR-T, Gene Therapy
- Active Programs
- 413 confirmed from ClinicalTrials.gov across 116 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO 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 Inspections8 on record
Warning Letters0
Last InspectionOfficial Action Indicated (OAI) (2025-09-16)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
413
Sponsors116
ModalitiesCAR-T, Gene Therapy
413 active programs across 116 sponsors
Modalities: Gene Therapy, CAR-T
275 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07443137
CAR-T ceLL for Eradication of Active Residual Disease in LBCL...
PHASE1
Not Yet Recruiting
NCT05469828
Crizanlizumab Improves Tissue Oxygen Supply Demand Matching...
PHASE1/PHASE2
Not Yet Recruiting
NCT06456138
Trametinib Plus Anlotinib Combined With Tislelizumab in...
PHASE1/PHASE2
Not Yet Recruiting
NCT06430671
Peptide-coupled Red Blood Cells for the Treatment of Multiple...
PHASE1
Active Not Recruiting
View all 135 programs →
Source: ClinicalTrials.gov · Retrieved Mar 23, 2026
Financial Stability
78.0
Publicly traded — financial transparency
Source: SEC EDGAR, press monitoring
28 SEC filings with industry mentions on record
SEC Filings28 with industry mentions
Publicly traded — financial transparency
Capacity
82.0
3 manufacturing sites
Active facility expansion (5 articles)
Sites: Morris Plains, NJ, Stein, Switzerland, Les Ulis, France
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Recent Press20 articles
3 manufacturing sites
Active facility expansion (5 articles)
FDA Inspection History
2025-09
2025-06
2025-03
2024-11
2024-08
2024-08
2024-07
2024-06
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-16 | Selaqui | Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2025-06-25 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2025-03-03 | East Hanover, New Jersey | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-11-19 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-08-29 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-08-08 | Morris Plains, New Jersey | Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
| 2024-07-12 | Ahmedabad | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-06-27 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Mar 23, 2026
Clinical Activity 135 studies
NCT07443137
CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)
PHASE1
Not Yet Recruiting
NCT07250087
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse...
PHASE1
Recruiting
NCT06964958
177LuPSMA in Renal Cell Carcinoma
PHASE2
Active Not Recruiting
NCT05469828
Crizanlizumab Improves Tissue Oxygen Supply Demand Matching in Patients With...
PHASE1/PHASE2
Not Yet Recruiting
NCT06456138
Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC
PHASE1/PHASE2
Not Yet Recruiting
NCT06430671
Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
PHASE1
Active Not Recruiting
NCT06395402
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
PHASE2
Recruiting
NCT05567055
Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases...
PHASE2
Withdrawn
NCT05714891
Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer
PHASE2
Active Not Recruiting
NCT06662825
Real World Patient Characteristics and Treatment Patterns From Crizanlizumab...
NA
Completed
NCT06662825
Real World Patient Characteristics and Treatment Patterns From Crizanlizumab...
NA
Completed
NCT05472220
Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and...
PHASE1
Withdrawn
NCT06271369
Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.
NA
Completed
NCT05435846
Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell...
PHASE1
Terminated
NCT04894370
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With...
PHASE2
Recruiting
NCT05479448
Predictive Factors for Treatment Response in Patients With Newly-diagnosed...
NA
Recruiting
NCT05199961
Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With...
NA
Terminated
NCT04890236
Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With...
EARLY_PHASE1
Completed
NCT02645149
Molecular Profiling and Matched Targeted Therapy for Patients With...
PHASE2
Completed
NCT05080218
COVID-19 VaccinE Response in Rheumatology Patients
PHASE4
Completed
+ 115 more studies
Source: ClinicalTrials.gov · Retrieved Mar 23, 2026
Financial Intelligence
"We face a challenge to attract and retain top talent in several areas, including biology, immunology, chemistry, clinical development, drug manufacturing, data, digital and IT, including AI, oncology, and advanced therapy platforms (i.e., gene and cell therapy, radioligand therapy, and xRNA)."
"In addition, we manufacture and sell a number of sterile products, biologic products, and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, or require a supply of highly specialized raw materials, such as cell lines, tissue samples, bacteria, viral strains, and radioisotopes."
"The T315I mutation causes resistance to most available TKI therapies, and, as a result, patients with this mutation would otherwise have limited treatment options
•
Zolgensma
(onasemnogene abeparvovec)/
Itvisma
(onasemnogene abeparvovec-brve) is a one-time gene therapy designed to address the genetic root cause of spinal muscular atrophy (SMA) by replacing the function of the missing or nonworking SMN1 gene."
"“The SMA disease landscape has dramatically changed over the last
six years, when the first gene therapy was approved."
"Novartis has an exclusive, worldwide license with Nationwide Children's Hospital to both the intravenous
and intrathecal delivery of adeno-associated virus 9 (AAV9) gene replacement therapy for the treatment of all types of SMA; an exclusive,
worldwide license from REGENXBIO for any recombinant AAV vector in its intellectual property portfolio for the
in vivo
gene replacement
therapy treatment of SMA in humans; an exclusive, worldwide licensing agreement with Généthon for
in vivo
delivery
of AAV"
"We face a challenge to attract and retain top talent in several areas, including biology, immunology, chemistry, clinical development, drug manufacturing, data, digital and IT, oncology, and advanced therapy platforms (i.e., gene and cell therapy, radioligand therapy and xRNA) and to maintain and strengthen our employer reputation."
"In addition, we manufacture and sell a number of sterile products, biologic products and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, all of which are particularly complex and involve highly specialized manufacturing technologies."
"In addition, we manufacture and sell a number of sterile products, biologic products, and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, all of which are particularly complex and involve highly specialized manufacturing technologies."
"OAV101 IT is the first investigational
gene therapy to provide clinical benefit in treatment-naïve patients with SMA aged two
and older with a positive risk benefit profile"
"7
The results from the
Phase III STEER study add to the clinical data and emerging real-world evidence for the use
of one-time gene therapy to treat SMA."
"About
OAV101 IT
Intrathecal onasemnogene abeparvovec (OAV101 IT) is an investigational,
one-time gene therapy for patients with spinal muscular atrophy (SMA)."
Source: SEC EDGAR · Retrieved Mar 23, 2026
Recent News 20 articles
Novartis to boost multidimensional investments - China Daily
Novartis to boost multidimensional investments China Daily
Novartis to build radioligand therapy site in Texas to expand US manufacturing - MSN
Novartis to build radioligand therapy site in Texas to expand US manufacturing MSN
Novartis CEO says expanded US production limits tariff risk - MSN
Novartis CEO says expanded US production limits tariff risk MSN
Human Gene Therapy Market Set to Boom Through 2033 | Novartis • Gilead Sciences • Spark Therapeutics - openPR.com
Human Gene Therapy Market Set to Boom Through 2033 | Novartis • Gilead Sciences • Spark Therapeutics openPR.com
Sandoz to set up standalone biosimilars unit as it eyes upcoming 'golden decade' of patent losses - Fierce Pharma
Sandoz to set up standalone biosimilars unit as it eyes upcoming 'golden decade' of patent losses Fierce Pharma
Novartis, Nucor partner US Forged Rings and others expand domestic investments - Manufacturing Dive
Novartis, Nucor partner US Forged Rings and others expand domestic investments Manufacturing Dive
Novartis, Nucor partner US Forged Rings and others expand domestic investments - Yahoo Finance
Novartis, Nucor partner US Forged Rings and others expand domestic investments Yahoo Finance
Novartis to Build New Radioligand Therapy Site in Denton, Texas - Contract Pharma
Novartis to Build New Radioligand Therapy Site in Denton, Texas Contract Pharma
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th - Bitget
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th Bitget
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th - Bitget
Novartis Gains 0.59% on Gene Therapy Expansion and Digital Health Push as Trading Volume Ranks 365th bitget.com
Why is Big Pharma expanding cleanroom manufacturing for advanced therapies in the US? - Cleanroom Technology
Why is Big Pharma expanding cleanroom manufacturing for advanced therapies in the US? Cleanroom Technology
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 - Yahoo Finance UK
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 Yahoo Finance UK
Novartis plans radioligand therapy manufacturing site in Texas - DOTmed
Novartis plans radioligand therapy manufacturing site in Texas DOTmed
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 - Yahoo Finance
AI in Pharma Manufacturing Market Research 2026-2040: Pfizer, Moderna, Novartis, Merck, and Sanofi are Integrating AI Into Their Operations As the Sector Evolves Towards Pharma 4.0 Yahoo Finance
Novartis (NVS) Announces Plans to Establish a New Radioligand Therapy Manufacturing Site in Denton, Texas - Yahoo Finance
Novartis (NVS) Announces Plans to Establish a New Radioligand Therapy Manufacturing Site in Denton, Texas Yahoo Finance
Novartis (NVS) Announces Plans to Establish a New Radioligand Therapy Manufacturing Site in Denton, Texas - Finviz
Novartis (NVS) Announces Plans to Establish a New Radioligand Therapy Manufacturing Site in Denton, Texas Finviz
Novartis (NVS) Announces Plans to Establish a New Radioligand Therapy Manufacturing Site in Denton, Texas - Bitget
Novartis (NVS) Announces Plans to Establish a New Radioligand Therapy Manufacturing Site in Denton, Texas Bitget
Novartis selects Denton for new factory as part of $23 billion US expansion - WFAA
Novartis selects Denton for new factory as part of $23 billion US expansion WFAA
Novartis to site fifth radioligand therapy manufacturing facility in Texas - European Pharmaceutical Review
Novartis to site fifth radioligand therapy manufacturing facility in Texas European Pharmaceutical Review
Novartis to Build $23B Radioligand Therapy Manufacturing Hub in Texas - Thomasnet
Novartis to Build $23B Radioligand Therapy Manufacturing Hub in Texas Thomasnet
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