Bayer: AskBio receives FDA decision
(CercleFinance.com) - AskBio receives Advanced Regenerative Medicine Gene Therapy designation from the US Food and Drug Administration (FDA) for investigational gene therapy for Parkinson's disease.
AskBio is a 100% owned and independently operated gene therapy company as a subsidiary of Bayer.
The Regenerative Medicine Advanced Gene Therapy (RMAT) designation follows 36-month Phase Ib data.
The study demonstrated a favorable safety profile and continued positive trends in evaluated clinical outcome measures of the investigational gene therapy AB-1005 with no product-related serious adverse events.
The FDA's decision to grant RMAT designation to AB-1005 is excellent news for people with Parkinson's disease and their loved ones, AskBio.
This important milestone could potentially accelerate the development of our important investigational gene therapy program, and it highlights our promising data and the potential of AB-1005 for patients and the medical community.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
AskBio is a 100% owned and independently operated gene therapy company as a subsidiary of Bayer.
The Regenerative Medicine Advanced Gene Therapy (RMAT) designation follows 36-month Phase Ib data.
The study demonstrated a favorable safety profile and continued positive trends in evaluated clinical outcome measures of the investigational gene therapy AB-1005 with no product-related serious adverse events.
The FDA's decision to grant RMAT designation to AB-1005 is excellent news for people with Parkinson's disease and their loved ones, AskBio.
This important milestone could potentially accelerate the development of our important investigational gene therapy program, and it highlights our promising data and the potential of AB-1005 for patients and the medical community.
Copyright (c) 2025 CercleFinance.com. All rights reserved.