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Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease
globenewswire.com

Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease

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.

Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber Neuropathy
globenewswire.com

Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber Neuropathy

RICHMOND, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.

Sangamo Therapeutics Announces FDA Acceptance of BLA Rolling Submission Request for ST-920 in Fabry Disease
globenewswire.com

Sangamo Therapeutics Announces FDA Acceptance of BLA Rolling Submission Request for ST-920 in Fabry Disease

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.

Sangamo Therapeutics, Inc. (SGMO) Q3 2025 Earnings Call Transcript
seekingalpha.com

Sangamo Therapeutics, Inc. (SGMO) Q3 2025 Earnings Call Transcript

Sangamo Therapeutics, Inc. ( SGMO ) Q3 2025 Earnings Call November 6, 2025 8:30 AM EST Company Participants Louise Wilkie - Head of Global Corporate Communications & Investor Relations Alexander Macrae - CEO, President & Director Nathalie Dubois-Stringfellow - Senior VP & Chief Development Officer Prathyusha Duraibabu - Interim Principal Financial Officer Gregory Davis - Head of Research & Technology Conference Call Participants Hang Hu - Barclays Bank PLC, Research Division Maurice Raycroft - Jefferies LLC, Research Division Kuan-Hung Lin Luis Santos Presentation Operator Good morning, and welcome to Sangamo Therapeutics Third Quarter 2025 Conference Call. Please be advised that today's conference is being recorded.

Sangamo Therapeutics Reports Recent Business Highlights and Third Quarter 2025 Financial Results
globenewswire.com

Sangamo Therapeutics Reports Recent Business Highlights and Third Quarter 2025 Financial Results

Held meeting with U.S. Food and Drug Administration (FDA) where, among other things, they reiterated October 2024 agreement to use estimated glomerular filtration rate (eGFR) slope as an endpoint to support accelerated approval pathway for isaralgagene civaparvovec in Fabry disease. Presented detailed clinical data from registrational STAAR study showing potential for isaralgagene civaparvovec as a one-time, durable treatment of underlying pathology of Fabry disease to provide meaningful, multi-organ, clinical benefits above current standards of care.

Sangamo Therapeutics Presents Detailed Data from Registrational STAAR Study in Fabry Disease at International Congress of Inborn Errors of Metabolism 2025
globenewswire.com

Sangamo Therapeutics Presents Detailed Data from Registrational STAAR Study in Fabry Disease at International Congress of Inborn Errors of Metabolism 2025

Totality of data supports potential for isaralgagene civaparvovec as a one-time, durable treatment of the underlying pathology of Fabry disease to provide meaningful, multi-organ, clinical benefits above current standards of care 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 primary basis of approval Isaralgagene civaparvovec showed a favorable safety and tolerability profile Sangamo intends to submit a Biologics License Application (BLA) in 2026 under the Accelerated Approval pathway RICHMOND, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced detailed data from the registrational Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease.

Sangamo Therapeutics, Inc. (SGMO) Q2 2025 Earnings Call Transcript
seekingalpha.com

Sangamo Therapeutics, Inc. (SGMO) Q2 2025 Earnings Call Transcript

Sangamo Therapeutics, Inc. (NASDAQ:SGMO ) Q2 2025 Earnings Conference Call August 7, 2025 4:30 PM ET Company Participants Alexander D. Macrae - CEO, President & Director Gregory Davis - Head of Research & Technology Louise Wilkie - Head of Global Corporate Communications & Investor Relations Nathalie Dubois-Stringfellow - Senior VP & Chief Development Officer Prathyusha Duraibabu - Senior VP, CFO & Principal Accounting Officer Conference Call Participants James D Stamos - Jefferies LLC, Research Division Joshua Seth Fleishman - TD Cowen, Research Division Kuan-Hung Lin - Unidentified Company Liu Deng - Barclays Bank PLC, Research Division Luis Santos - Unidentified Company Operator Good afternoon, and welcome to the Sangamo Therapeutics Second Quarter 2025 Teleconference Call.

Sangamo Therapeutics Reports Recent Business Highlights and Second Quarter 2025 Financial Results
globenewswire.com

Sangamo Therapeutics Reports Recent Business Highlights and Second Quarter 2025 Financial Results

Announced positive topline results from registrational STAAR study in Fabry disease, including 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 primary basis of approval. First clinical site initiated for Phase 1/2 STAND study in chronic neuropathic pain.

Sangamo Therapeutics, Inc. (SGMO) Q1 2025 Earnings Call Transcript
seekingalpha.com

Sangamo Therapeutics, Inc. (SGMO) Q1 2025 Earnings Call Transcript

Sangamo Therapeutics, Inc. (NASDAQ:SGMO ) Q1 2025 Earnings Conference Call May 12, 2025 6:30 PM ET Company Participants Louise Wilkie - Vice President, Investor Relations and Corporate Communications Sandy Macrae - Chief Executive Officer Nathalie Dubois-Stringfellow - Chief Development Officer Prathyusha Duraibabu - Chief Financial Officer Conference Call Participants Nicole Germino - Truist Luis Santos - H.C. Wainwright Operator Good afternoon and welcome to the Sangamo Therapeutics First Quarter 2025 Teleconference Call.

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