21 November 2025 - Sangamo Therapeutics today announced that the US FDA has accepted Sangamo’s request for a rolling submission and review of the biologics license application for isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease.

This acceptance follows Sangamo’s meeting with the FDA in October 2025 to discuss the proposed efficacy and safety data package for isaralgagene civaparvovec where, in the meeting minutes, among other things, the FDA reiterated its October 2024 agreement to use eGFR slope as an endpoint to support an accelerated approval pathway.

Isaralgagene civaparvovec has been granted orphan drug, fast track and RMAT designations from the FDA, orphan medicinal product designation and PRIME eligibility from the EMA and Innovative Licensing and Access Pathway from UK Medicines and Healthcare products Regulatory Agency.

Sangamo plans to initiate rolling submission of the BLA to the FDA under the accelerated approval pathway later in the fourth quarter of 2025.

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