AskBio’s gene therapy AB-1005 granted FDA’s RMAT status

AB-1005, AskBio’s investigational gene therapy for Parkinson’s disease, has been granted regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA). RMAT designation is intended to speed the development and review of therapies that have shown potential to treat serious or life-threatening conditions. Benefits…

Gene therapy AB-1005 found safe in Phase 1b Parkinson’s trial

Treatment with AB-1005 (AAV2-GDNF), AskBio’s investigational gene therapy, was safe and well tolerated among patients with mild to moderate Parkinson’s disease, according to top-line results from a Phase 1b clinical trial. The company, wholly owned by Bayer, has also completed an 18-month data collection which demonstrated the…