FDA Events for CARGO Therapeutics (CRGX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by CARGO Therapeutics (CRGX).
Over the past two years, CARGO Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Firi-cel. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Firi-cel - FDA Regulatory Timeline and Events
Firi-cel is a drug developed by CARGO Therapeutics for the following indication: for patients with large B-cell lymphoma (LBCL).
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.
- Drug:
- Firi-cel
- Announced Date:
- January 29, 2025
- Indication:
- for patients with large B-cell lymphoma (LBCL)
Announcement
CARGO Therapeutics, announced that it has elected to discontinue FIRCE-1, a Phase 2 clinical study of firi-cel for patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy.
AI Summary
CARGO Therapeutics announced that it is discontinuing its FIRCE-1 Phase 2 study of firicabtagene autoleucel (firi-cel) for patients with large B-cell lymphoma whose disease has relapsed or is refractory to CD19 CAR T-cell therapy. An ad hoc analysis raised safety concerns, including a high rate of serious immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) in 18% of patients, and the durability of complete response at three months was only 18%. These factors led the company to conclude that firi-cel does not offer a competitive benefit-risk profile for these patients.
Along with halting the FIRCE-1 study, CARGO Therapeutics will reduce its workforce by approximately 50% to extend its cash runway while focusing on advancing its CRG-023 candidate into a Phase 1 study and evaluating other strategic options.
Read Announcement
CARGO Therapeutics FDA Events - Frequently Asked Questions
As of now, CARGO Therapeutics (CRGX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, CARGO Therapeutics (CRGX) has reported FDA regulatory activity for Firi-cel.
The most recent FDA-related event for CARGO Therapeutics occurred on January 29, 2025, involving Firi-cel. The update was categorized as "Discontinue," with the company reporting: "CARGO Therapeutics, announced that it has elected to discontinue FIRCE-1, a Phase 2 clinical study of firi-cel for patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy."
Currently, CARGO Therapeutics has one therapy (Firi-cel) targeting the following condition: for patients with large B-cell lymphoma (LBCL).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:CRGX) was last updated on 7/11/2025 by MarketBeat.com Staff
Free CRGX Stock Alerts