11:10 AM EDT, 10/22/2024 (MT Newswires) -- Sangamo Therapeutics ( SGMO ) shares surged past 31% in recent Tuesday trading after the genomic medicine company said the US Food and Drug Administration has laid out a clear pathway for accelerated approval for its ST-920 gene therapy candidate for the treatment of Fabry disease.
Fabry disease is a genetic condition characterized by the body's inability to break down a certain type of fat.
The FDA agreed that the estimated glomerular filtration rate slope data at 52 weeks in the phase 1/2 Staar study can serve as the primary basis for potential accelerated approval, the company said. A glomerular filtration rate is a test used to check kidney function.
Sangamo said it expects to submit a biologics license application for ST-920 in H2 of 2025, three years sooner than expected, as the complete data from the current study will be available in H1 of 2025.
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