Sangamo Therapeutics initiates rolling submission of BLA to US FDA for ST-920 in Fabry disease

Sangamo Therapeutics

18 December 2025 - Sangamo expects to complete biological license application submission under accelerated approval pathway in second quarter of 2026.

Sangamo Therapeutics has initiated a rolling submission of a biological license application to the FDA seeking accelerated approval of isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease.

Read Sangamo Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration