Sangamo Therapeutics Begins FDA Rolling Submission for ST-920 Gene Therapy in Fabry Disease

Reuters12-18 21:05

Sangamo <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Begins FDA Rolling Submission for ST-920 Gene Therapy in Fabry Disease

Sangamo Therapeutics Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of isaralgagene civaparvovec (ST-920), an investigational gene therapy for adults with Fabry disease. The FDA has agreed that the positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52 weeks from the STAAR study will serve as an endpoint to support the accelerated approval pathway. Isaralgagene civaparvovec has also received Orphan Drug, Fast Track, and RMAT designations from the FDA, as well as similar regulatory incentives from European and U.K. agencies. Sangamo expects to complete the BLA submission in the second quarter of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sangamo Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9604388) on December 18, 2025, and is solely responsible for the information contained therein.

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