Sangamo Therapeutics Inc. hat mit der rollierenden Einreichung eines Biologics License Application (BLA) bei der US-amerikanischen Food and Drug Administration (FDA) im Rahmen des Accelerated Approval Programms für das Gentherapieprodukt Isaralgagene civaparvovec (ST-920) zur Behandlung der Fabry-Krankheit begonnen. Die FDA hat zugestimmt, dass die Daten aus der abgeschlossenen Phase 1⁄2 STAAR-Studie als primäre Grundlage für die Zulassung verwendet werden können, wobei der mittlere annualisierte eGFR-Slope nach 52 Wochen als intermediärer klinischer Endpunkt dient. 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 on February 03, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here

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Sangamo Therapeutics Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for its gene therapy product Isaralgagene civaparvovec (ST-920) aimed at treating Fabry disease. The FDA has agreed to use data from the completed Phase 1/2 STAAR study as the primary basis for approval, with the mean annualized eGFR slope after 52 weeks serving as an intermediate clinical endpoint.

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FDA prüft Zulassungsantrag für Sangamos Gentherapie bei Fabry-Krankheit