Axolabs (Nuvisan)

Kulmbach, DE
Oligonucleotide
3 confirmed programs · 2 sponsors · Last scored 2026-04-29
72.6
Signal Score
✓ FDA Inspections (1) ✓ Clinical Trials (3) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Axolabs (Nuvisan)

Signal Score
72.6/100 (as of 2026-04-29)
Quality Compliance
98.9/100
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

About Axolabs (Nuvisan)

Pure-play CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 98.9
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 Jul 04, 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

Axolabs (Nuvisan) 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 Jul 04, 2026

Frequently Asked Questions About Axolabs (Nuvisan)

How many FDA inspections does Axolabs (Nuvisan) have on record?
CDMO Signal tracks 1 FDA inspection for Axolabs (Nuvisan), sourced from the FDA inspection database. See the full inspection history above.
Has Axolabs (Nuvisan) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Axolabs (Nuvisan).
How many clinical programs is Axolabs (Nuvisan) linked to?
Axolabs (Nuvisan) is associated with 3 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Axolabs (Nuvisan)'s CDMO Signal Score?
Axolabs (Nuvisan) has a Signal Score of 73/100, based on quality, operations, financial stability, and capacity data.
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