U.S. FDA grants fast track designation to three Passage Bio gene therapy candidates targeting rare CNS disorders

Passage Bio

8 March 2021 - FDA designation will facilitate development and expedited review of company’s lead gene therapy product candidates for life-threatening diseases with unmet medical needs.

Passage Bio today announced the U.S. FDA has granted fast track designation to the company’s three lead investigational gene therapies: PBGM01 for the treatment of GM1 gangliosidosis (GM1), PBFT02 for frontotemporal dementia with granulin mutations (FTD-GRN), and PBKR03 for Krabbe disease.

Read Passage Bio press release

Michael Wonder

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Michael Wonder

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US , Gene therapy , Fast track