10:03 AM EST, 11/21/2025 (MT Newswires) -- Sangamo Therapeutics ( SGMO ) said Friday the US Food and Drug Administration accepted its request for rolling review of a biologics license application for isaralgagene civaparvovec to treat adults with Fabry disease.

The company said the decision follows an October meeting during which the agency confirmed that eGFR slope as an endpoint would support an accelerated approval pathway, consistent with an earlier agreement from 2024.

Sangamo added that data from its phase 1/2 study presented in September showed the gene therapy could offer significant benefits exceeding current standards.

Sangamo plans to begin the rolling submission to the FDA later in Q4, it said

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