FDA Events for Kiromic BioPharma (KRBP)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Kiromic BioPharma (KRBP).
Over the past two years, Kiromic BioPharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Deltacel. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Deltacel (KB-GDT-01) - FDA Regulatory Timeline and Events
Deltacel (KB-GDT-01) is a drug developed by Kiromic BioPharma for the following indication: .
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:
- Deltacel (KB-GDT-01)
- Announced Date:
- August 14, 2024
- Indication:
Announcement
Kiromic BioPharma, Inc announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel™ (KB-GDT-01), the Company's allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy.
AI Summary
Kiromic BioPharma announced that the FDA has granted Fast Track designation to its investigational therapy Deltacel™ (KB-GDT-01). This designation is intended to speed up the development and review process for promising treatments that address serious conditions. Deltacel, an off-the-shelf Gamma Delta T-cell (GDT) therapy, is being studied in combination with low-dose radiation for patients with metastatic non-small cell lung cancer who have not responded to multiple prior therapies.
The Fast Track status allows Kiromic to work more closely with the FDA with more frequent communications and a potential priority review. The designation recognizes the innovative approach of using donor-derived GDT cells to target advanced lung cancer. This milestone supports ongoing clinical evaluation in the Phase 1 trial, aiming to improve progression-free and overall survival for patients with limited treatment options.
Read Announcement- Drug:
- Deltacel (KB-GDT-01)
- Announced Date:
- June 20, 2024
- Indication:
Announcement
Kiromic BioPharma, Inc reports follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial.
AI Summary
Kiromic BioPharma, Inc. reported follow-up results from the second, third, and fourth patients in its Deltacel-01 Phase 1 trial. The study tests Deltacel™, an off-the-shelf gamma delta T-cell therapy, for stage 4 metastatic non-small cell lung cancer patients who have not responded to standard therapies.
The third and fourth patients showed stable disease at their four- and two-month visits without dose-limiting toxicities. The second patient, who had already shown stable disease and a complete response in brain metastasis, experienced a new sub-cutaneous metastasis. Due to this, the FDA and Institutional Review Board (IRB) quickly approved a single-use, single-patient treatment protocol under a new IND. This protocol involves a new course with low-dose radiation combined with gamma delta T cells, aiming to control any new or progressing lesions in the patient.
Read Announcement- Drug:
- Deltacel (KB-GDT-01)
- Announced Date:
- April 24, 2024
- Indication:
Announcement
Kiromic BioPharma, Inc announces consistentfavorable safety, tolerability, and efficacy from follow-up visits of the first cohort of three patients enrolled in the Company's Deltacel-01 Phase 1 clinical trial..
AI Summary
Kiromic BioPharma, Inc. announced encouraging follow-up data from the first three patients enrolled in its Deltacel-01 Phase 1 trial. The trial is testing Deltacel™, the company’s allogeneic, off-the-shelf Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer. Follow-up visits showed that all three patients experienced consistent safety and tolerability, with no dose-limiting toxicities observed. Two months after treatment, Patients 2 and 3 demonstrated stable disease, while imaging confirmed Patient 2 had no brain metastases. Four months after treatment, the first patient continued to show stable disease, including a 6.6% reduction in the size of the primary tumor.
Based on these promising results, Kiromic plans to apply for Fast Track Designation from the FDA by the end of the second quarter, a move that could help expedite the drug’s review process and potentially bring this transformative treatment to market faster.
Read Announcement
Kiromic BioPharma FDA Events - Frequently Asked Questions
As of now, Kiromic BioPharma (KRBP) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Kiromic BioPharma (KRBP) has reported FDA regulatory activity for Deltacel (KB-GDT-01).
The most recent FDA-related event for Kiromic BioPharma occurred on August 14, 2024, involving Deltacel (KB-GDT-01). The update was categorized as "Designation Grant," with the company reporting: "Kiromic BioPharma, Inc announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel™ (KB-GDT-01), the Company's allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy."
Currently, Kiromic BioPharma does not have any FDA drugs targeting specific conditions or diseases.
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:KRBP) was last updated on 7/13/2025 by MarketBeat.com Staff
