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Century Therapeutics (IPSC) FDA Events

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FDA Events for Century Therapeutics (IPSC)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Century Therapeutics (IPSC). Over the past two years, Century Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CNTY-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

CNTY-101 - FDA Regulatory Timeline and Events

CNTY-101 is a drug developed by Century Therapeutics for the following indication: Relapsed or refractory CD19 positive B-cell malignancies. 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.

Century Therapeutics FDA Events - Frequently Asked Questions

As of now, Century Therapeutics (IPSC) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Century Therapeutics (IPSC) has reported FDA regulatory activity for CNTY-101.

The most recent FDA-related event for Century Therapeutics occurred on May 28, 2025, involving CNTY-101. The update was categorized as "Presentation," with the company reporting: "Century Therapeutics, Inc. announced two presentations at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is being held from June 11-14, 2025, at Fira de Barcelona in Barcelona, Spain."

Currently, Century Therapeutics has one therapy (CNTY-101) targeting the following condition: Relapsed or refractory CD19 positive B-cell malignancies.

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