SGMO News & Events

The company said, "This financial guidance is subject to our ability to secure adequate additional funding for our current operating plan."

Reports Q4 revenue $14.23M vs. $7.55M last year. "Sangamo continued to make significant pipeline progress since the start of 2025. Following positive topline results from our registrational STAAR study in Fabry disease, we are well advanced in the rolling submission of the BLA to the FDA under the Accelerated Approval pathway," said Sandy Macrae, CEO of Sangamo. "In 2025, we also became a clinical-stage neurology company, with recruitment having commenced in the Phase 1/2 STAND study in small fiber neuropathy, and we continued to demonstrate that we are a collaborator of choice for neurotropic capsids, with the announcement of our third STAC-BBB capsid license agreement."

Sangamo Therapeutics announced advancement of the rolling submission of a BLA to the FDA seeking accelerated approval of isaralgagene civaparvovec, or ST-920. Following initiation of the rolling submission in December 2025, Sangamo has now submitted the preclinical and clinical modules to the FDA for review. Rolling submission allows for completed modules of the BLA to be submitted and reviewed by the FDA on an ongoing basis rather than waiting for the entire BLA to be submitted at once. In addition, the antibody assay companion diagnostic, which is designed to screen patients for eligibility with isaralgagene civaparvovec, has been submitted to, and accepted by, the FDA's Center for Devices and Radiological Health seeking Premarket Approval.