Axolabs (Nuvisan)

Kulmbach, DE
Oligonucleotide
3 confirmed programs · 2 sponsors · Last scored 2026-04-02
72.5
Signal Score
✓ FDA Inspections (1) ✓ Clinical Trials (3) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Axolabs (Nuvisan)

Signal Score
72.5/100 (as of 2026-04-02)
Quality Compliance
98.8/100
Headquarters
Kulmbach, DE
Modalities
Oligonucleotide
Active Programs
3 confirmed from ClinicalTrials.gov across 2 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 98.8
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2024-10-17)
Operations 55.0
3 active programs across 2 sponsors
Modalities: Oligonucleotide
Source: ClinicalTrials.gov
3 active programs across 2 sponsors · Modalities: Oligonucleotide
Programs 3
Sponsors2
ModalitiesOligonucleotide
3 active programs across 2 sponsors
Modalities: Oligonucleotide
Source: ClinicalTrials.gov facility matching
NCT03492437 Effect of Tepotinib on the PK of the P-gp Substrate... PHASE1 Completed
NCT03531762 Effect of a Proton Pump Inhibitor on the PK of Tepotinib PHASE1 Completed
NCT01258660 Assessment of the Pharmacodynamic Effect on Plasma Folate and... PHASE1 Completed
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026
Financial Stability 68.0
Parent company: Nuvisan
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Nuvisan
Financial assessment: 68.0/100
Capacity 53.0
1 manufacturing site: Kulmbach, DE
Modalities: Oligonucleotide
Capacity assessment: 53.0/100
Sites: Kulmbach, DE
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Kulmbach, DE
Modalities: Oligonucleotide
Capacity assessment: 53.0/100

FDA Inspection History

2024-10
NAI VAI OAI
Date Site Type Observations Classification
2024-10-17 Neu-Ulm Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026
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