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...
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. Fast Track Designation aims to facilitate the development and expedite the review of new the...
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. This acceptance follows Sangamo’s meeting with the FDA...
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...
Sangamo Therapeutics Announces Third Quarter 2025 Earnings Call RICHMOND, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the company has scheduled the release of its third quarter 2025 financial results before the market opens on Thursday, November 6, 2025. The company will hold a conference call at 8:30 a.m. Eastern on Thursday, November 6, which will remain open to the public. During the conference call, the company will review its financial results and provide business updates. Participants should ...
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 wi...
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. Expect to dose first patient in fall of 2025, with preliminary proof of efficacy data anticip...
Sangamo Therapeutics Announces Second Quarter 2025 Earnings Call RICHMOND, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company today announced that the company has scheduled the release of its second quarter 2025 financial results after the markets close on Thursday, August 7, 2025. The company will hold a conference call at 4:30 p.m. Eastern on Thursday, August 7, which will remain open to the public. During the conference call, the company will review its financial results and provide business updates. Participants should reg...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today reported recent business highlights and fourth quarter and full year 2024 financial results. “I am pleased with Sangamo’s pipeline progress since the start of 2024. We advanced our two prioritized neurology therapies towards the clinic, securing our first ever neurology IND; we showed we are a collaborator of choice for neurotropic capsids, with the announcement of two blue-chip pharma agreements for our STAC-BBB capsid, with negotiations advancing for a third potential agreement; ...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company today announced that the company has scheduled the release of its fourth quarter and full year 2024 financial results after the markets close on Monday, March 17, 2025. The company also plans to participate in an upcoming investor conference. Fourth Quarter and Full Year 2024 Earnings Results The company will hold its fourth quarter and full year 2024 results conference call at 4:30 p.m. Eastern on Monday, March 17, which will remain open to the public. During the conference call, the co...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced updated data from the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. Updated data continue to support the potential of isaralgagene civaparvovec as a one-time, durable treatment option for Fabry disease that can improve patient outcomes. These data will be presented at the 21st Annual WORLDSymposiumTM in San Diego, CA on February 6, 2025, in an oral presentation in t...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced it will regain development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for the treatment of adults with moderately severe to severe hemophilia A that it has co-developed with, and licensed to Pfizer Inc., following a decision by Pfizer to terminate the global collaboration and license agreement between the parties. Sangamo intends to explore all options to advance the program, including seeking a potential ...
RICHMOND, Calif. & TOKYO--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced they have entered into a license agreement allowing Astellas to leverage Sangamo’s novel proprietary neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, which has demonstrated potent blood-brain barrier penetration and neuronal transduction in nonhuman primates. The agreement grants Astellas a worldwide exclusive license to utilize the STAC-BBB capsid for one target, with the ...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for its ST-503 program, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN), a type of chronic neuropathic pain. Neuropathic pain can be caused by a broad array of pathologies impacting the central or peripheral nervous systems, such as surgical trauma, spinal cord injury, nerve compression, ...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today reported business highlights and third quarter 2024 financial results. “This is a pivotal time for Sangamo as we build upon our recent strong momentum with news of a clear regulatory pathway to Accelerated Approval in the U.S. for ST-920 in Fabry disease, accelerating time to potential approval by approximately three years,” said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. “Alongside Pfizer’s Hemophilia A program activities, and against a backdrop of our recent ...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, announced today that the company has scheduled the release of its third quarter 2024 financial results after the market close on Tuesday, November 12, 2024. The company will hold a conference call at 4:30 p.m. Eastern on Tuesday, November 12, which will remain open to the public. During the conference call, the company will review its financial results and provide business updates. Participants should register for, and access, the call using . While not required, it is recommended to jo...
RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced the outcome of a recent successful interaction with the U.S. FDA, providing a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease. The FDA has agreed in a Type B interaction that data from the ongoing Phase 1/2 STAAR study can serve as the primary basis for approval under the Accelerated Approval Program, using eGFR slope at 52 weeks across all patient...
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