Sangamo Therapeutics Announces Important Regulatory Updates for ST-920 in Fabry Disease

- U.S. Food and Drug Administration (FDA) advises that a single study with up to 25 patients, in combination with confirmatory evidence, may be acceptable pathway to Biologics License Application (BLA) submission for isaralgagene civaparvovec, which would significantly reduce anticipated complexity, cost, and time to potential approval.

- European Medicines Agency (EMA) granted priority medicines (PRIME) eligibility to isaralgagene civaparvovec, which includes enhanced regulatory support and scientific guidance.

- Sangamo is actively seeking a collaboration partner to advance isaralgagene civaparvovec through potential registration and commercialization.

On February 12, 2024, Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, announced important U.S. and European regulatory updates for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease.

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