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Sangamo Therapeutics (SGMO) FDA Events

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FDA Events for Sangamo Therapeutics (SGMO)

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-503 and ST-920. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Sangamo Therapeutics' Drugs in FDA Review

ST-503 - FDA Regulatory Timeline and 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.

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.

Sangamo Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Sangamo Therapeutics (SGMO) has reported FDA regulatory activity for the following drugs: ST-920 and ST-503.

The most recent FDA-related event for Sangamo Therapeutics occurred on June 24, 2025, involving ST-920. The update was categorized as "Top-line results," with the company reporting: "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."

Current therapies from Sangamo Therapeutics in review with the FDA target conditions such as:

  • FabryDisease - ST-920
  • For the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain - ST-503

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:SGMO) was last updated on 7/10/2025 by MarketBeat.com Staff
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