FDA Events for MiNK Therapeutics (INKT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by MiNK Therapeutics (INKT).
Over the past two years, MiNK Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AgenT-797. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AgenT-797 - FDA Regulatory Timeline and Events
AgenT-797 is a drug developed by MiNK Therapeutics for the following indication: Multiple myeloma.
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:
- AgenT-797
- Announced Date:
- July 11, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment with agenT-797, MiNK's allogeneic iNKT cell therapy.
AI Summary
MiNK Therapeutics, Inc. recently announced a major breakthrough in the treatment of metastatic, treatment-refractory testicular cancer. The company published a landmark case in Nature’s Oncogene showing that a patient who had exhausted several therapies, including platinum-based chemotherapy, autologous stem cell transplant, and multiple immune checkpoint inhibitors, achieved a complete and durable remission. This success came after the patient received a single infusion of MiNK’s allogeneic iNKT cell therapy, agenT-797, along with nivolumab. The case demonstrated that the donor iNKT cells remained detectable for up to six months post-infusion, and the treatment was well-tolerated without severe side effects such as cytokine release syndrome or graft-versus-host disease. These promising findings underscore the potential of agenT-797 to offer new hope for patients with difficult-to-treat cancers and support further clinical studies in this area.
Read Announcement
MiNK Therapeutics FDA Events - Frequently Asked Questions
As of now, MiNK Therapeutics (INKT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, MiNK Therapeutics (INKT) has reported FDA regulatory activity for AgenT-797.
The most recent FDA-related event for MiNK Therapeutics occurred on July 11, 2025, involving AgenT-797. The update was categorized as "Publication," with the company reporting: "MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment with agenT-797, MiNK's allogeneic iNKT cell therapy."
Currently, MiNK Therapeutics has one therapy (AgenT-797) targeting the following condition: Multiple myeloma.
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:INKT) was last updated on 7/12/2025 by MarketBeat.com Staff
