Nkarta's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Nkarta (NKTX).
Over the past two years, Nkarta has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NKX019. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NKX019 FDA Regulatory Timeline and Events
NKX019 is a drug developed by Nkarta for the following indication: Relapsed/refractory 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.
- Drug:
- NKX019
- Announced Date:
- April 15, 2026
- Indication:
- Relapsed/refractory B cell malignancies
Announcement
Nkarta, Inc.announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on key changes to the ongoing Ntrust-1 and Ntrust-2 clinical trials.
AI Summary
Nkarta, Inc. announced it has reached agreement with the U.S. Food and Drug Administration on key changes to its ongoing Ntrust-1 and Ntrust-2 clinical trials. The agreed amendments allow outpatient administration for both studies and give the sponsors the option to re-dose participants if needed to optimize individual responses. Nkarta said the amended protocol must complete IRB review before new steps begin.
Once finalized, the Ntrust-2 trial will add a rheumatoid arthritis cohort, expanding the program to address another autoimmune disease with high unmet need. The changes also remove geographic monitoring requirements, reducing patient burden. The Ntrust trials continue to enroll people with lupus nephritis, primary membranous nephropathy, systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis, with RA expected to be added after IRB approval of the amendment.
Read Announcement- Drug:
- NKX019
- Announced Date:
- October 22, 2025
- Indication:
- Relapsed/refractory B cell malignancies
Announcement
Nkarta, Inc. announced it will be presenting a poster this Sunday in Chicago at the American College of Rheumatology (ACR) Convergence 2025 meeting.
AI Summary
Nkarta, Inc., a clinical-stage biopharmaceutical company, will present a poster this Sunday at the ACR Convergence 2025 meeting in Chicago. The poster focuses on NKX019, its off-the-shelf natural killer cell therapy.
In clinical data, NKX019 strongly reduced harmful B cells in lymphoma patients. Normal B cells returned after treatment, suggesting an immune reset.
Preclinical studies in animal models showed NKX019 depletes disease-driving B cells, moves to lymphoid organs, and spreads to tissues. This supports its potential to treat B-cell driven autoimmune diseases.
Poster details:
Title: “NKX019, an allogeneic off-the-shelf CD19 targeting CAR-NK cell therapy, induces deep CD19+ B cell depletion in hematological malignancy and models of autoimmune disease”
Presenter: Mira Tohmé
Date: Sunday, Oct. 26, 10:30 AM–12:30 PM, Hall F1
Submission #: 2130624, Poster #: 0014
Nkarta will also have a booth (#1801) where attendees can meet its team and learn more about ongoing clinical programs.
Read Announcement- Drug:
- NKX019
- Announced Date:
- December 5, 2024
- Indication:
- Relapsed/refractory B cell malignancies
Announcement
Nkarta, Inc. announced the opening of Ntrust-2 to enrollment and the IND clearance for an investigator-sponsored trial (IST) that will evaluate NKX019, Nkarta's allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy, in patients with myasthenia gravis (MG).
AI Summary
Nkarta, Inc. announced that its Ntrust-2 clinical trial is now open for enrollment. This multi-center trial will treat patients with systemic sclerosis, myositis, and ANCA-associated vasculitis using NKX019, an allogeneic, CD19-directed CAR NK-cell therapy designed to eliminate harmful B cells in autoimmune diseases.
In addition, the company received IND clearance for an investigator-sponsored trial (IST) focused on myasthenia gravis. Led by researchers from the University of California, Irvine and the University of Kansas Medical Center, the IST will assess NKX019’s safety, clinical outcomes, and its ability to “reset” the immune system by depleting CD19-positive B cells. This approach may offer a treatment alternative that reduces the need for continuous dosing in myasthenia gravis patients. Clinical data from these evaluations are expected to be released in 2025.
Read Announcement- Drug:
- NKX019
- Announced Date:
- December 5, 2024
- Indication:
- Relapsed/refractory B cell malignancies
Announcement
Nkarta, Inc. announced that Clinical data from Ntrust-1 and Ntrust-2 planned for 2025
AI Summary
Nkarta, Inc. has announced that preliminary clinical data from its ongoing Ntrust-1 and Ntrust-2 trials will be available in 2025. These trials focus on the use of NKX019, an allogeneic, CD19-directed chimeric antigen receptor (CAR) natural killer (NK) cell therapy, aimed at addressing challenging autoimmune diseases.
In particular, Ntrust-2 is open for enrolling patients across three parallel cohorts diagnosed with systemic sclerosis, myositis, and ANCA-associated vasculitis. In addition, an investigator-sponsored trial is evaluating NKX019 in patients with myasthenia gravis. The study design includes multiple dosing cycles following lymphodepletion, aiming to provide a potential “reset” of the immune system while minimizing long-term toxicity.
The planned release of clinical data in 2025 is eagerly anticipated as it may shed light on the safety and potential benefits of NKX019 in treating these autoimmune conditions.
Read Announcement- Drug:
- NKX019
- Announced Date:
- July 24, 2024
- Indication:
- Relapsed/refractory B cell malignancies
Announcement
Nkarta, Inc. announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial ("IST") of NKX019, Nkarta's allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic lupus erythematosus (SLE).
AI Summary
Researchers at Columbia University Irving Medical Center (CUIMC) have started an investigator-sponsored trial (IST) to study NKX019, Nkarta’s allogeneic, CD19-directed CAR NK-cell therapy, for patients with systemic lupus erythematosus (SLE). This trial is designed to include up to six patients with SLE, regardless of renal involvement, which allows evaluation in a potentially broader patient population compared to other ongoing studies focusing on lupus nephritis.
The study, led by Dr. Anca D. Askanase, Director of the Lupus Center at CUIMC, aims to assess the safety and clinical outcomes of NKX019. Researchers plan to monitor various biomarkers including autoantibodies, cytokine profiles, and pharmacokinetics. Patients will receive multiple doses of NKX019 following a lymphodepletion regimen, marking an important step toward finding a long-term, medication-free remission for lupus patients.
Read Announcement- Drug:
- NKX019
- Announced Date:
- June 27, 2024
- Indication:
- Relapsed/refractory B cell malignancies
Announcement
Nkarta, Inc. announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening.
AI Summary
Nkarta, Inc. has launched Ntrust-1, the first U.S. clinical trial testing its engineered natural killer cell therapy, NKX019, for the treatment of lupus nephritis. The multi-center study has begun screening patients, marking a significant step in offering a potentially safer and more accessible treatment for those with this severe form of lupus.
Lupus nephritis is a challenging condition where the immune system mistakenly attacks the kidneys. NKX019 is designed to target CD19-positive B cells, which play a key role in the disease. This therapy is unique because it does not require additional antibodies or external cytokines, which could help reduce toxicity and side effects. Nkarta hopes that the results from Ntrust-1 will help improve outcomes and pave the way for further advances in cell therapy for autoimmune diseases.
Read Announcement- Drug:
- NKX019
- Announced Date:
- June 27, 2024
- Indication:
- Relapsed/refractory B cell malignancies
Announcement
Nkarta, Inc. announced that Clinical data from Ntrust-1 and Ntrust-2 planned for 2025
AI Summary
Nkarta, Inc. announced that clinical data from its two trials, Ntrust-1 and Ntrust-2, is expected in 2025. Ntrust-1 is the first U.S.-based clinical trial testing an engineered NK cell therapy for lupus nephritis, with patients already undergoing screening. Meanwhile, Ntrust-2 will study the same therapy for systemic sclerosis, myositis, and vasculitis. The company is using these trials to evaluate a new off-the-shelf natural killer (NK) cell treatment that targets B-cell mediated diseases without the need for antibodies or extra cytokines. By planning to present these clinical data next year, Nkarta aims to provide important insights into the safety and potential effectiveness of its novel approach for treating various autoimmune conditions. This step is seen as a major milestone in Nkarta’s mission to deliver more accessible and safer cell therapies.
Read Announcement
Nkarta FDA Events - Frequently Asked Questions
As of now, Nkarta (NKTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Nkarta (NKTX) has reported FDA regulatory activity for NKX019.
The most recent FDA-related event for Nkarta occurred on April 15, 2026, involving NKX019. The update was categorized as "Provided Update," with the company reporting: "Nkarta, Inc.announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on key changes to the ongoing Ntrust-1 and Ntrust-2 clinical trials."
Currently, Nkarta has one therapy (NKX019) targeting the following condition: Relapsed/refractory B cell malignancies.
More FDA Event Resources from MarketBeat
Companies With Recent FDA Events
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
FDA progress for NASDAQ:NKTX last updated on 4/16/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
Free NKTX Stock Alerts