PASG - Passage Bio gene therapies win FDA fast track status

Passage Bio (PASG) announces 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.Fast Track designation facilitates the expedited development and review of a new drug that demonstrates potential to address unmet medical needs and treats a serious or life-threatening disease.Passage Bio plans to initiate clinical trials in GM1 in Q1 of 2021 and in FTD-GRN and Krabbe disease in the first half of 2021.Shares up nearly 3% premarket.

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Passage Bio gene therapies win FDA fast track status