Nkarta (NKTX) FDA Approvals

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.

Provided Update - September 8,2026

• Drug: NKX019
• Announced Date: September 8, 2026
• Indication: Relapsed/refractory B cell malignancies

Nkarta, Inc. announced its selection for three scientific presentations at ACR Convergence 2026 being held November 6-11 in Orlando.

Provided Update - April 15,2026

• Drug: NKX019
• Announced Date: April 15, 2026
• Indication: Relapsed/refractory B cell malignancies

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.

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.

Poster Presentation - October 22,2025

• Drug: NKX019
• Announced Date: October 22, 2025
• Indication: Relapsed/refractory B cell malignancies

Nkarta, Inc. announced it will be presenting a poster this Sunday in Chicago at the American College of Rheumatology (ACR) Convergence 2025 meeting.

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.

Enrollment Update - December 5,2024

• Drug: NKX019
• Announced Date: December 5, 2024
• Indication: Relapsed/refractory B cell malignancies

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).

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.

Clinical Data - December 5,2024

• Drug: NKX019
• Announced Date: December 5, 2024
• Indication: Relapsed/refractory B cell malignancies

Nkarta, Inc. announced that Clinical data from Ntrust-1 and Ntrust-2 planned for 2025

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.