Sangamo Therapeutics, Inc. (NASDAQ: SGMO) shares moved marginally higher Tuesday. The Richmond, Calif.-based genomic medicine company, today announced that the U.S. Food and Drug Administration) 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, 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.”
SGMO shares acquired three cents, or 6%, to 45 cents.
