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Legend Biotech (LEGN) FDA Events

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FDA Events for Legend Biotech (LEGN)

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

Ciltacabtagene Autoleucel (cilta-cel) - FDA Regulatory Timeline and Events

Ciltacabtagene Autoleucel (cilta-cel) is a drug developed by Legend Biotech for the following indication: Relapsed and/or Refractory Multiple Myeloma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Legend Biotech FDA Events - Frequently Asked Questions

Yes, Legend Biotech (LEGN) has received FDA approval for Ciltacabtagene Autoleucel (cilta-cel). This page tracks recent and historical FDA regulatory events related to Legend Biotech's drug portfolio.

In the past two years, Legend Biotech (LEGN) has reported FDA regulatory activity for Ciltacabtagene Autoleucel (cilta-cel).

The most recent FDA-related event for Legend Biotech occurred on June 3, 2025, involving Ciltacabtagene Autoleucel (cilta-cel). The update was categorized as "Results," with the company reporting: "Legend Biotech Corporation announced new long-term results from the CARTITUDE-1 study in heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients."

Currently, Legend Biotech has one therapy (Ciltacabtagene Autoleucel (cilta-cel)) targeting the following condition: Relapsed and/or Refractory Multiple Myeloma.

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:LEGN) was last updated on 7/9/2025 by MarketBeat.com Staff
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