Axolabs (Nuvisan)

Kulmbach, Germany
Oligonucleotide
No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07
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 2026-09-07)
Quality Compliance
99.0/100
Headquarters
Kulmbach, Germany
Modalities
Oligonucleotide
Active Programs
Data pending
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

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 99.0
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2024-10-17)
Operations 55.0
Programs — no verified data
Sponsors— no verified data
ModalitiesOligonucleotide
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
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 Oct 07, 2026
Financial Stability 68.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity 53.0
Profile-based capacity assessment

Axolabs (Nuvisan) FDA Inspection History

2024-10
NAI VAI OAI
Date Site Type Observations Classification
2024-10-17
Nuvisan GmbH
Neu-Ulm Facility-linked
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 07, 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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