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Sangamo Therapeutics Announces Derisking Milestones For Pathway To Anticipated BLA Submission For ST-920 In Fabry Disease

Author: Benzinga Newsdesk | May 06, 2025 07:36am

All dosed patients have passed one-year milestone required by U.S. Food and Drug Administration (FDA) for Accelerated Approval regulatory pathway for ST-920.
According to preliminary analysis, mean estimated glomerular filtration rate (eGFR) slope at 52-weeks continued to remain positive.
Productive Type B Chemistry, Manufacturing and Controls (CMC) meeting with FDA provided clear CMC pathway to planned Biologics License Application (BLA) submission.
Pivotal data readout expected by end of second quarter of 2025.

Posted In: SGMO