Welcome to our dedicated page for Sangamo Therapeutics news (Ticker: SGMO), a resource for investors and traders seeking the latest updates and insights on Sangamo Therapeutics stock.
Sangamo Therapeutics, Inc. (Nasdaq: SGMO) is a genomic medicine company whose news flow centers on clinical data, regulatory interactions, collaborations and financial updates across its neurology‑focused pipeline. Company announcements emphasize investigational programs in Fabry disease, chronic neuropathic pain and prion disease, along with progress in its zinc finger epigenetic regulation and AAV capsid platforms.
A major theme in recent SGMO news is the development of isaralgagene civaparvovec (ST‑920), a wholly owned investigational gene therapy for adults with Fabry disease. Press releases detail topline and updated results from the registrational Phase 1/2 STAAR study, including positive mean annualized estimated glomerular filtration rate (eGFR) slopes at 52 and 104 weeks, stability of cardiac endpoints, biomarker trends and quality‑of‑life measures. Regulatory milestones, such as FDA agreement to use eGFR slope as an endpoint for an accelerated approval pathway and acceptance of a rolling Biologics License Application (BLA) submission, are also key subjects.
Investors following SGMO news can also track developments in the Phase 1/2 STAND study of ST‑503 for intractable pain due to small fiber neuropathy, including FDA Fast Track Designation, site activation and recruitment updates. Additional releases describe preclinical and regulatory progress for ST‑506 in prion disease, as well as business development activities like the capsid license agreement with Eli Lilly and Company and other collaboration‑related revenues.
Quarterly earnings releases and conference call announcements provide context on Sangamo’s operating expenses, cash position and strategic focus on a neurology‑oriented genomic medicine business. For readers interested in SGMO, this news page aggregates these clinical, regulatory, partnership and financial disclosures in one place, making it easier to follow the company’s reported milestones over time.
Sangamo Therapeutics (Nasdaq: SGMO) has initiated a rolling submission of a Biological License Application (BLA) to the U.S. FDA seeking accelerated approval for isaralgagene civaparvovec (ST-920) to treat adults with Fabry disease.
The registrational STAAR study showed a positive mean annualized eGFR slope at 52 weeks across dosed patients, and the FDA agreed that eGFR slope will serve as an endpoint to support accelerated approval. Sangamo expects to complete the BLA submission under the accelerated pathway in Q2 2026. ST-920 has received Orphan Drug, Fast Track, and RMAT designations from the FDA and regulatory recognitions from EMA and UK regulators.
Sangamo Therapeutics (NASDAQ: SGMO) announced that the U.S. FDA granted Fast Track Designation to ST-503 for the treatment of intractable pain from small fiber neuropathy (SFN).
The designation may enable more frequent FDA interactions and could make ST-503 eligible for Accelerated Approval or Priority Review if criteria are met. ST-503 is an investigational epigenetic regulator currently in the Phase 1/2 STAND study, with patient recruitment underway and first dosing expected in the coming months. Sangamo previously presented nonclinical data showing durability, potency, selectivity and a favorable safety profile in nonhuman primates.
Sangamo Therapeutics (Nasdaq: SGMO) announced the FDA has accepted its request for a rolling submission and review of the Biologics License Application (BLA) for isaralgagene civaparvovec (ST-920) for adults with Fabry disease.
The FDA reiterated its prior agreement to use eGFR slope as an endpoint to support an accelerated approval pathway. Sangamo said the registrational Phase 1/2 STAAR study showed a positive mean annualized eGFR slope at 52 weeks across dosed patients and that the company plans to initiate rolling BLA submission later in Q4 2025. ST-920 holds multiple regulatory designations including Orphan Drug, Fast Track, RMAT, EMA PRIME and UK Innovative Licensing pathway.
Sangamo Therapeutics (Nasdaq: SGMO) reported Q3 2025 results and program updates on Nov 6, 2025. Key clinical highlights include detailed STAAR registrational data for isaralgagene civaparvovec (ST-920) in Fabry disease showing a positive mean annualized eGFR slope 1.965 mL/min/1.73m2/year at 52 weeks (n=32) and durability of α-Gal A activity up to 4.5 years. FDA reiterated use of eGFR slope to support an accelerated approval pathway; company preparing for a potential BLA as early as Q1 2026. Neurology updates: Phase 1/2 STAND enrollment started for ST-503 with first dosing expected in coming months; ST-506 CTA expected as early as mid-2026. Financials: Q3 net loss $34.9M, revenues $0.6M (vs $49.4M prior year), cash $29.6M as of Sept 30, 2025, with Nasdaq minimum bid extension to April 27, 2026.
Sangamo Therapeutics (NASDAQ: SGMO) announced it will release Q3 2025 financial results before the market opens on Thursday, November 6, 2025. The company will host a public conference call and webcast at 8:30 a.m. ET on November 6, 2025 to review results and provide business updates.
Participants should register in advance to receive a dial‑in number and unique passcode or use the dial‑out option; joining 10 minutes early is recommended. The live webcast link is available in the Investors and Media > Events section of the Sangamo website, and a replay will be posted after the call.
Sangamo Therapeutics (Nasdaq: SGMO) has presented detailed data from its registrational Phase 1/2 STAAR study of isaralgagene civaparvovec (ST-920), a gene therapy for Fabry disease. The study demonstrated a positive mean annualized eGFR slope of 1.965 mL/min/1.73m2/year at 52 weeks across all 32 dosed patients.
Key highlights include stable cardiac function, sustained α-Gal A activity for up to 4.5 years, and successful withdrawal of all 18 patients from Enzyme Replacement Therapy (ERT). The therapy showed a favorable safety profile without requiring preconditioning, with mostly grade 1-2 adverse events.
Sangamo plans to submit a Biologics License Application (BLA) in Q1 2026 under the Accelerated Approval pathway. The therapy has received multiple regulatory designations, including Fast Track and RMAT from FDA.
Sangamo Therapeutics (Nasdaq: SGMO) reported significant progress in Q2 2025, highlighted by positive topline results from their registrational STAAR study for Fabry disease treatment. The study showed a positive mean annualized eGFR slope of 1.965 mL/min/1.73m2/year at 52-weeks across all 32 patients, supporting potential FDA Accelerated Approval.
Financial results showed a reduced net loss of $20.0 million ($0.08 per share) compared to $36.1 million in Q2 2024. Revenues increased to $18.3 million, primarily from Eli Lilly's upfront license payment. Cash position stands at $38.3 million, expected to fund operations into Q4 2025.
The company initiated its first clinical site for the Phase 1/2 STAND study in chronic neuropathic pain, with first patient dosing expected fall 2025. Sangamo plans to submit a BLA for its Fabry disease treatment by Q1 2026.
Sangamo Therapeutics (Nasdaq: SGMO), a genomic medicine company, has scheduled its second quarter 2025 financial results release for Thursday, August 7, 2025, after market close. The company will host a conference call at 4:30 p.m. Eastern the same day to discuss financial results and provide business updates.
Participants can register and access the call through a provided link, with a recommended join time of 10 minutes before the event. The webcast will be available in the Investors and Media section of Sangamo's website, with a replay accessible after the call.
[]Sangamo Therapeutics (Nasdaq: SGMO) announced positive topline results from its registrational Phase 1/2 STAAR study for isaralgagene civaparvovec (ST-920), a gene therapy for Fabry disease. The study demonstrated a positive mean annualized eGFR slope of 1.965 mL/min/1.73m2/year at 52 weeks across all 32 patients, which will serve as the primary basis for FDA approval.
Key highlights include maintained elevated α-Gal A activity for up to 4.5 years, successful withdrawal of all 18 patients from enzyme replacement therapy (ERT), and significant improvements in quality of life scores. The therapy showed a favorable safety profile without preconditioning requirements. Sangamo plans to submit a Biologics License Application (BLA) in Q1 2026 under the Accelerated Approval pathway.
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