Asklepios BioPharmaceutical (AskBio)

Research Triangle, NC · San Sebastian, ES

Hybrid — also manufactures internal programs

AAV

10 confirmed programs · 4 sponsors · Last scored 2026-04-29

61.8

Signal Score

○ FDA Inspections ✓ Clinical Trials (10) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Asklepios BioPharmaceutical (AskBio)

Signal Score: 61.8/100 (as of 2026-04-29)
Quality Compliance: Assessment pending
Headquarters: Research Triangle, NC · San Sebastian, ES
Modalities: AAV
Active Programs: 10 confirmed from ClinicalTrials.gov across 4 sponsors
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About Asklepios BioPharmaceutical (AskBio)

Hybrid developer + CDMO.

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 InspectionsNo US records on file

No FDA inspection records found for this manufacturer

Quality score requires FDA inspection data

Operations

10 active programs across 4 sponsors · Modalities: AAV · 5 programs in advanced phases (Phase 2/3)

Programs 10

Sponsors4

ModalitiesAAV

10 active programs across 4 sponsors

Modalities: AAV

5 programs in advanced phases (Phase 2/3)

Source: ClinicalTrials.gov facility matching

NCT07566429 A Study of AB-1005 Gene Therapy in Japanese Adults With... PHASE2 Not Yet Recruiting

NCT07282847 A Study to Evaluate Safety, Tolerability, and Efficacy of... PHASE1/PHASE2 Recruiting

NCT07081841 AB-1005 Long-Term Follow-up Study NA Enrolling By Invitation

NCT06285643 A Study of AAV2-GDNF in Adults With Moderate Parkinson's... PHASE2 Recruiting

NCT05598333 Phosphatase Inhibition by Intracoronary Gene Therapy in... PHASE2 Active Not Recruiting

NCT05230459 A Study to Evaluate the Safety of AB-1003 (Previously... PHASE1/PHASE2 Recruiting

NCT05699460 Pre-Gene Therapy Study in Parkinson's Disease and Multiple... NA Active Not Recruiting

NCT04167540 GDNF Gene Therapy for Parkinson's Disease PHASE1 Active Not Recruiting

NCT03533673 AAV2/8-LSPhGAA (ACTUS-101) in Late-Onset Pompe Disease PHASE1 Completed

NCT00428935 Safety Study of Mini-dystrophin Gene to Treat Duchenne... PHASE1 Completed

Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Parent company: Bayer

Financial assessment: 68.0/100

Capacity

2 manufacturing sites

Asklepios BioPharmaceutical (AskBio) FDA 483 Findings 5 observations · 2025-11-18 → 2025-11-18 ?

By subsystem

Documentation & Records 4 (80.0%)
Other 1 (20.0%)

By severity

2 — Minor: 5
Repeat observations: 0

Most severe findings

Minor (2) Documentation & Records 2025-11-18 21 CFR 111.260

Batch record - required information

"Your batch production record did not include all required information."
Minor (2) Other 2025-11-18 21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

"You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations."
Minor (2) Documentation & Records 2025-11-18 21 CFR 111.70(e)

Specifications - finished dietary supplement

"You did not establish product specifications for identity, purity, strength and composition."

About this data →

Clinical Activity 10 studies

NCT07566429 A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's... PHASE2 Not Yet Recruiting NCT07282847 A Study to Evaluate Safety, Tolerability, and Efficacy of AB-1009 Gene... PHASE1/PHASE2 Recruiting NCT07081841 AB-1005 Long-Term Follow-up Study NA Enrolling By Invitation NCT06285643 A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD) PHASE2 Recruiting NCT05598333 Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With... PHASE2 Active Not Recruiting NCT05230459 A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects... PHASE1/PHASE2 Recruiting NCT05699460 Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy NA Active Not Recruiting NCT04167540 GDNF Gene Therapy for Parkinson's Disease PHASE1 Active Not Recruiting NCT03533673 AAV2/8-LSPhGAA (ACTUS-101) in Late-Onset Pompe Disease PHASE1 Completed NCT00428935 Safety Study of Mini-dystrophin Gene to Treat Duchenne Muscular Dystrophy PHASE1 Completed

Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Frequently Asked Questions About Asklepios BioPharmaceutical (AskBio)

How many clinical programs is Asklepios BioPharmaceutical (AskBio) linked to?

Asklepios BioPharmaceutical (AskBio) is associated with 10 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.

What is Asklepios BioPharmaceutical (AskBio)'s CDMO Signal Score?

Asklepios BioPharmaceutical (AskBio) has a Signal Score of 62/100, based on quality, operations, financial stability, and capacity data.

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