Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease
Sangamo Therapeutics, Inc. (SGMO)
Last sangamo therapeutics, inc. earnings: 2/28 07:00 am
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Source: GlobeNewswire
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as an endpoint to support accelerated approval pathway Isaralgagene civaparvovec continues to show favorable safety and tolerability profile Sangamo expects to complete Biological License Application (BLA) submission under accelerated approval pathway in second quarter of 2026 RICHMOND, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, has initiated a rolling submission of a BLA to the FDA seeking accelerated approval of isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease. Rolling submission allows for completed modules of the BLA to be submitted and reviewed by the FDA on an ongoing basis rather than waiting for the entire
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News
- Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease [Yahoo! Finance]Yahoo! Finance
- How the Narrative Surrounding Sangamo Therapeutics Is Shifting After New Regulatory and Valuation Signals [Yahoo! Finance]Yahoo! Finance
- Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber NeuropathyGlobeNewswire
- How Recent Developments Are Rewriting the Story for Sangamo Therapeutics [Yahoo! Finance]Yahoo! Finance
- Sangamo Therapeutics Announces FDA Acceptance of BLA Rolling Submission Request for ST-920 in Fabry Disease [Yahoo! Finance]Yahoo! Finance
SGMO
Earnings
- 11/6/25 - Miss
SGMO
Sec Filings
- 11/26/25 - Form 4
- 11/26/25 - Form 4
- 11/26/25 - Form 4
- SGMO's page on the SEC website