This section highlights FDA-related milestones and regulatory updates for drugs developed by Sangamo Therapeutics (SGMO).
Over the past two years, Sangamo Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ST-920 and ST-503. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ST-920 FDA Regulatory Timeline and Events
ST-920 is a drug developed by Sangamo Therapeutics for the following indication: FabryDisease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ST-920
- Announced Date:
- March 9, 2026
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, nnounced advancement of the 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.
AI Summary
Sangamo Therapeutics said it advanced the rolling submission of a biologics license application (BLA) to the FDA seeking accelerated approval of isaralgagene civaparvovec (ST-920), a gene therapy for adults with Fabry disease. It has submitted preclinical and clinical modules for FDA review under a rolling process, which lets the agency review completed portions as they are filed rather than waiting for the full package.
Sangamo also submitted an antibody-assay companion diagnostic to the FDA’s Center for Devices and Radiological Health, which accepted the device for Premarket Approval review. The diagnostic is meant to screen patients for eligibility for ST-920.
Company data show ST-920 may be a one-time, well-tolerated, durable therapy with potential multi-organ benefits. In the STAAR study, patients across dose groups showed a positive mean annualized eGFR slope at 52 weeks, and that eGFR change will serve as the endpoint to support accelerated approval.
Read Announcement- Drug:
- ST-920
- Announced Date:
- February 3, 2026
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, Inc announced detailed data from the registrational Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.
AI Summary
Sangamo Therapeutics announced detailed results from the Phase 1/2 STAAR study of isaralgagene civaparvovec (ST-920), a gene therapy candidate for Fabry disease. The company says the data show ST-920 may work as a one-time treatment that is well tolerated and durable. Sangamo highlights potential meaningful clinical benefits across multiple organs, which could change how Fabry disease is treated.
Key findings include a positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52 weeks across all dosed patients, indicating possible kidney benefit. Sangamo plans to share full details in a Current Report on Form 8‑K and at WORLDSymposium 2026 presentations and poster sessions. The company views the totality of the STAAR data as supportive of ST-920’s potential to provide long‑lasting, multi-organ improvement for people with Fabry disease.
Read Announcement- Drug:
- ST-920
- Announced Date:
- December 18, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, 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.
AI Summary
Sangamo Therapeutics has begun a rolling submission of a Biologics License Application (BLA) to the FDA seeking accelerated approval of isaralgagene civaparvovec (ST-920), a wholly owned investigational gene therapy for adults with Fabry disease. ST-920 is being developed as a one-time intravenous infusion intended to address the underlying cause. Sangamo expects to complete the BLA submission under the accelerated approval pathway in the second quarter of 2026, with the FDA reviewing modules as they are filed.
Data from the Phase 1/2 STAAR study showed a positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52 weeks across all dosed patients, which the FDA agreed will serve as an endpoint to support accelerated approval. ST-920 has shown a favorable safety and tolerability profile in the study, and Sangamo says the totality of data suggest potential durable, multi-organ clinical benefits.
Read Announcement- Drug:
- ST-920
- Announced Date:
- November 21, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, 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.
AI Summary
The U.S. Food and Drug Administration has accepted Sangamo Therapeutics' request for a rolling submission and review of the Biologics License Application (BLA) for isaralgagene civaparvovec (ST-920), an investigational one-time gene therapy for adults with Fabry disease. Sangamo said it plans to begin the rolling BLA submission later in the fourth quarter of 2025 and called the acceptance an important step toward potential approval.
Data from the Phase 1/2 STAAR study presented by Sangamo showed that ST-920 may offer durable, multi-organ benefits above current care, including a positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52 weeks across dosed patients. Sangamo described ST-920 as a one-time infusion and said the 52-week eGFR results will serve as the primary basis for its approval strategy as it moves forward with the rolling BLA.
Read Announcement- Drug:
- ST-920
- Announced Date:
- September 4, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics 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.
AI Summary
Sangamo Therapeutics presented detailed results from the Phase 1/2 STAAR study of isaralgagene civaparvovec (ST-920), a one-time gene therapy for adults with Fabry disease. In 32 dosed patients, the study showed a positive mean annualized eGFR slope of 1.965 mL/min/1.73 m²/year at 52 weeks and 1.747 at 104 weeks, indicating improved kidney function compared to treatments. Benefits were consistent across patient subgroups, including gender and enzyme replacement status. Cardiac measures, such as left ventricular mass and strain, remained stable. Alpha-galactosidase A activity stayed elevated for up to 4.5 years in the longest-treated patient, and participants stopped enzyme replacement therapy without a rise in disease markers. Quality of life scores, like physical role and vitality, improved significantly. Safety data showed mainly mild to moderate adverse events with no study discontinuations. Sangamo plans to file a Biologics License Application in 2026 via Accelerated Approval pathway.
Read Announcement- Drug:
- ST-920
- Announced Date:
- June 24, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, Inc announced positive topline results 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.
AI Summary
Sangamo Therapeutics, Inc. announced positive topline results from its Phase 1/2 STAAR study evaluating isaralgagene civaparvovec (ST-920), an investigational gene therapy for adults with Fabry disease. The study showed a positive mean annualized eGFR slope of 1.965 mL/min/1.73m²/year at 52 weeks, which the FDA has agreed will serve as an intermediate clinical endpoint under Accelerated Approval. Among patients with 104 weeks of follow-up, similar improvements were observed, supporting the potential of ST-920 as a one-time, durable treatment for Fabry disease. The therapy demonstrated a favorable safety and tolerability profile with mostly mild side effects. Based on these encouraging results, Sangamo plans to submit a Biologics License Application (BLA) as early as the first quarter of 2026, aiming to offer a new option for managing the underlying pathology of Fabry disease.
Read Announcement- Drug:
- ST-920
- Announced Date:
- May 6, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, Inc announced important derisking events in the pathway to a planned BLA submission for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease.
AI Summary
Sangamo Therapeutics, Inc. announced important progress on the path to filing a Biologics License Application (BLA) for its gene therapy candidate, isaralgagene civaparvovec (ST‑920), which is designed to treat Fabry disease. All patients in the Phase 1/2 STAAR study have reached the 52‑week follow-up milestone, a key requirement by the FDA’s Accelerated Approval pathway. Preliminary data from these 32 patients show that the positive trend in kidney function, as measured by the mean eGFR slope, continues to hold, supporting the potential efficacy of the treatment.
Additionally, a recent productive Type B Chemistry, Manufacturing, and Controls meeting with the FDA has provided a clear pathway for refining the manufacturing process and planning for process validation. These derisking milestones bolster the company’s timeline toward a planned BLA submission in early 2026, with a pivotal data readout expected by the end of the second quarter of 2025.
Read Announcement- Drug:
- ST-920
- Announced Date:
- February 6, 2025
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, Inc. announced Data to support Accelerated Approval pathway expected in first half of 2025
AI Summary
Sangamo Therapeutics announced that data supporting the Accelerated Approval pathway for its gene therapy candidate, ST-920, are expected in the first half of 2025. This key data, specifically the 52‐week eGFR slope from the Phase 1/2 STAAR study, will serve as the primary efficacy endpoint in its regulatory submission to the FDA. The positive outcomes highlight improvements in kidney function among patients, reinforcing ST-920's potential as a one-time, durable treatment for Fabry disease.
Looking ahead, the company anticipates submitting a Biologics License Application in the second half of 2025. Sangamo’s continued progress in its clinical development, along with ongoing partnership discussions for ST-920, underlines its commitment to advancing innovative treatments that can significantly enhance patient outcomes.
Read Announcement- Drug:
- ST-920
- Announced Date:
- February 6, 2025
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, Inc announced that Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) anticipated in second half of 2025
AI Summary
Sangamo Therapeutics, Inc. recently announced encouraging progress with its gene therapy candidate, ST-920, for treating Fabry disease. The company revealed that data from its ongoing Phase 1/2 STAAR study will be available in the first half of 2025, supporting key measures of kidney function and patient safety. Based on these promising results, Sangamo plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the second half of 2025. This potential submission is part of an Accelerated Approval pathway that aims to expedite the process for bringing one-time, durable treatments to patients. Along with moving forward with regulatory plans, Sangamo is also pursuing business development discussions for a possible collaboration on ST-920, reflecting growing optimism about the therapy’s benefits and its impact on Fabry disease.
Read Announcement- Drug:
- ST-920
- Announced Date:
- February 6, 2025
- Indication:
- FabryDisease
Announcement
Sangamo Therapeutics, Inc 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.
AI Summary
Sangamo Therapeutics recently shared promising updated data from the Phase 1/2 STAAR study for its gene therapy candidate ST-920, which is being developed to treat Fabry disease. The study showed that patients experienced sustained benefits, with the longest treated patient maintaining elevated levels of the enzyme alpha-galactosidase A (α-Gal A) for nearly four years. In addition, 23 patients who reached at least one year of follow-up demonstrated a positive annualized improvement in kidney function as measured by eGFR. Significantly, all 18 patients who were receiving enzyme replacement therapy (ERT) were successfully withdrawn from ERT and have remained off it. These encouraging results support the potential of ST-920 as a one-time, durable treatment option that could improve patient outcomes in Fabry disease.
Read Announcement
ST-503 FDA Regulatory Events
ST-503 is a drug developed by Sangamo Therapeutics for the following indication: For the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ST-503
- Announced Date:
- December 2, 2025
- Indication:
- For the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain
Announcement
Sangamo Therapeutics, 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.
AI Summary
Sangamo Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track Designation to ST-503, an investigational epigenetic regulator being developed to treat intractable pain from small fiber neuropathy (SFN). ST-503 is aimed at chronic neuropathic pain that often does not respond to current therapies.
Fast Track designation is intended to help speed the development and review of therapies for serious conditions with unmet medical needs. The status allows more frequent interactions with the FDA and can make a program eligible for Accelerated Approval and Priority Review if relevant criteria are met.
Sangamo is enrolling patients in the Phase 1/2 STAND study, a randomized, sham‑controlled, dose‑escalation trial testing a one‑time intrathecal dose of ST-503 in adults with refractory SFN, and expects to dose the first patient soon. Company officials said the designation underscores the urgent need for safe, nonopioid treatment options. Nonclinical data showed durable, potent, and selective effects with a favorable safety profile in nonhuman primates, supporting continued development.
Read Announcement- Drug:
- ST-503
- Announced Date:
- November 19, 2024
- Indication:
- For the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain
Announcement
Sangamo Therapeutics, Inc 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.
AI Summary
Sangamo Therapeutics announced that the FDA has cleared its investigational new drug (IND) application for the ST-503 program. ST-503 is an investigational epigenetic regulator designed to treat intractable pain caused by idiopathic small fiber neuropathy (iSFN), a type of chronic neuropathic pain that severely affects patients. The therapy works by targeting the SCN9A gene, reducing the expression of the Nav1.7 sodium channel, which plays a critical role in pain signaling. Preclinical studies have shown that a single intrathecal dose of ST-503 significantly reduced pain symptoms in animal models without causing off-target effects.
Sangamo plans to start enrolling patients in a Phase 1/2 clinical study in mid-2025 to assess the safety, tolerability, and preliminary efficacy of ST-503. This milestone offers hope for patients suffering from debilitating, chronic neuropathic pain with few effective treatment options.
Read Announcement
