Trials & Filings

AskBio’s Gene Therapy Gets Fast Track

LION-101 is a recombinant adeno-associated virus (rAAV) based vector being developed as a one-time treatment for Limb-Girdle Muscular Dystrophy.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Asklepios BioPharmaceutical, Inc. (AskBio), a subsidiary of Bayer AG, was granted Fast Track Designation from the FDA for the LION-101 gene therapy program. LION-101 is a novel recombinant adeno-associated virus (rAAV) based vector being developed as a one-time intravenous infusion for the treatment of Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9).   The FDA recently cleared an Investigational New Drug (IND) application for LION-101, authorizing the start of a Phase 1/2 multicenter stu...

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