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0.0391638635271505 0.0180201826045171 0.00576645843344549 -0.01417587698222 0.0086496876501683 0.0569437770302739 0.0982700624699665 0.0266698702546852
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Sangamo Therapeutics Announces FDA Acceptance of BLA Rolling Submission Request for ST-920 in Fabry Disease

Sangamo Therapeutics, Inc. (SGMO) 
Last sangamo therapeutics, inc. earnings: 2/28 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: investor.sangamo.com
Company Research Source: GlobeNewswire
RICHMOND, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Sangamo’s request for a rolling submission and review of the Biologics License Application (BLA) for isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease. This acceptance follows Sangamo’s meeting with the FDA in October 2025 to discuss the proposed efficacy and safety data package for isaralgagene civaparvovec where, in the meeting minutes, among other things, the FDA reiterated its October 2024 agreement to use eGFR slope as an endpoint to support an accelerated approval pathway. “We are pleased to have received acceptance of our rolling submission and review request from the FDA, which follows our recent meeting to discuss the proposed efficacy and safety data package,” said Nathalie Dubois-Stringfellow, P Show less Read more
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