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Treace Medical Concepts (TMCI) FDA Events

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FDA Events for Treace Medical Concepts (TMCI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Treace Medical Concepts (TMCI). Over the past two years, Treace Medical Concepts has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ALIGN3D. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

ALIGN3D - FDA Regulatory Timeline and Events

ALIGN3D is a drug developed by Treace Medical Concepts for the following indication: Surgical treatment of Hallux Valgus. 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.

Treace Medical Concepts FDA Events - Frequently Asked Questions

As of now, Treace Medical Concepts (TMCI) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Treace Medical Concepts (TMCI) has reported FDA regulatory activity for ALIGN3D.

The most recent FDA-related event for Treace Medical Concepts occurred on March 28, 2025, involving ALIGN3D. The update was categorized as "Data Presentation," with the company reporting: "Treace Medical Concepts, Inc announced the presentation of updated interim data for the ALIGN3D™ and Mini3D™ Lapiplasty® clinical studies, as well as the first presentation of the MTA3D™ Adductoplasty® clinical study, at the 2025 American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting in Phoenix, Arizona."

Currently, Treace Medical Concepts has one therapy (ALIGN3D) targeting the following condition: Surgical treatment of Hallux Valgus.

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