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

Benzinga·05/06/2025 12:36:00
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  • 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.