Free Trial

Caribou Biosciences (CRBU) FDA Events

Caribou Biosciences logo
$1.76 +0.02 (+0.86%)
As of 03:06 PM Eastern
This is a fair market value price provided by Polygon.io. Learn more.
FDA Events for Caribou Biosciences (CRBU)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Caribou Biosciences (CRBU). Over the past two years, Caribou Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CB-010 and CB-012. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Caribou Biosciences' Drugs in FDA Review

CB-010 - FDA Regulatory Timeline and Events

CB-010 is a drug developed by Caribou Biosciences for the following indication: Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL. 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.

CB-012 - FDA Regulatory Timeline and Events

CB-012 is a drug developed by Caribou Biosciences for the following indication: For the Treatment of Relapsed or Refractory Acute Myeloid Leukemia. 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.

Caribou 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, Caribou Biosciences (CRBU) has reported FDA regulatory activity for the following drugs: CB-010 and CB-012.

The most recent FDA-related event for Caribou Biosciences occurred on April 24, 2025, involving CB-010. The update was categorized as "Clinical Data," with the company reporting: "Caribou Biosciences, Inc announced a strategic pipeline prioritization with workforce and cost reduction initiatives to focus resources on its lead oncology clinical programs CB-010 and CB-011, with clinical data disclosures now planned for H2 2025."

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

  • Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL - CB-010
  • For the Treatment of Relapsed or Refractory Acute Myeloid Leukemia - CB-012

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:CRBU) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners