Sangamo Therapeutics Begins Rolling BLA Submission to FDA for Fabry Disease Gene Therapy

Reuters05:09
Sangamo <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Begins Rolling BLA Submission to FDA for Fabry Disease Gene Therapy

Sangamo Therapeutics Inc. has initiated a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for isaralgagene civaparvovec (ST-920), a gene therapy candidate for Fabry disease. The submission is being made under the FDA's Accelerated Approval pathway, following the completion of the registrational Phase 1/2 STAAR study. The FDA has agreed that data from this study, specifically the mean annualized estimated glomerular filtration rate (eGFR) slope at 52 weeks, can serve as the primary basis for approval. No other beneficiary organizations are mentioned.

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