Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber Neuropathy

Sangamo Therapeutics, Inc., a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.

Fast Track Designation aims to facilitate the development and expedite the review of new therapeutics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Companies granted this designation are given the opportunity for more frequent interactions with the FDA. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

“We are very pleased to receive FDA Fast Track Designation for ST-503. SFN is a debilitating chronic pain disorder, with limited effective treatment options currently available,” said Nathalie Dubois-Stringfellow, Ph.D., Sangamo’s Chief Development Officer. “This designation underscores the high unmet patient need in SFN and the urgency to develop safe and effective nonopioid treatment alternatives. We are preparing to dose the first patient in our Phase 1/2 study and look forward to sharing data once available.”

ST-503 is currently being evaluated in the Phase 1/2 STAND study, where patient recruitment and enrollment are in progress. In September 2025, Sangamo presented updated nonclinical data highlighting the pharmacology and safety of ST-503 in chronic neuropathic pain at the 9th International Congress on Neuropathic Pain. The data demonstrated the durability, potency and selectivity of ST-503 in nonhuman primates, alongside a favorable safety profile, supporting its development for the treatment of chronic neuropathic pain. A copy of the presentation is available in the Presentations section of the Sangamo website. Sangamo expects to dose the first Phase 1/2 STAND study patient in the coming months.

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