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Tuesday, December 2, 2025

Sangamo rises as FDA grants Fast Track



Sangamo Therapeutics (NASDAQ: SGMO) announced that the U.S. FDA granted Fast Track Designation to ST-503 for the treatment of intractable pain from small fiber neuropathy (SFN).

The designation may enable more frequent FDA interactions and could make ST-503 eligible for Accelerated Approval or Priority Review if criteria are met. ST-503 is an investigational epigenetic regulator currently in the Phase 1/2 STAND study, with patient recruitment underway and first dosing expected in the coming months. Sangamo previously presented nonclinical data showing durability, potency, selectivity and a favorable safety profile in nonhuman primates.

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