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Solid Biosciences (SLDB) FDA Events

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FDA Events for Solid Biosciences (SLDB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Solid Biosciences (SLDB). Over the past two years, Solid Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SGT-003, SGT-212, and SGT-501. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Solid Biosciences' Drugs in FDA Review

SGT-003 - FDA Regulatory Timeline and Events

SGT-003 is a drug developed by Solid Biosciences for the following indication: For Duchenne Muscular Dystrophy Gene Therapy. 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.

SGT-212 - FDA Regulatory Timeline and Events

SGT-212 is a drug developed by Solid Biosciences for the following indication: For Treat Both Neurologic and Cardiac Manifestations of Friedreich's Ataxia. 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.

SGT-501 - FDA Regulatory Timeline and Events

SGT-501 is a drug developed by Solid Biosciences for the following indication: For the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT). 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.

Solid Biosciences FDA Events - Frequently Asked Questions

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

In the past two years, Solid Biosciences (SLDB) has reported FDA regulatory activity for the following drugs: SGT-003, SGT-212 and SGT-501.

The most recent FDA-related event for Solid Biosciences occurred on July 8, 2025, involving SGT-501. The update was categorized as "Clinical Trial," with the company reporting: "Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025 -"

Current therapies from Solid Biosciences in review with the FDA target conditions such as:

  • For Duchenne Muscular Dystrophy Gene Therapy - SGT-003
  • For Treat Both Neurologic and Cardiac Manifestations of Friedreich's Ataxia - SGT-212
  • For the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT) - SGT-501

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:SLDB) was last updated on 7/10/2025 by MarketBeat.com Staff
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