Nkarta (NKTX) FDA Approvals $2.68 0.00 (0.00%) Closing price 04:00 PM EasternExtended Trading$2.70 +0.02 (+0.71%) As of 06:21 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Nkarta's Drug in the FDA Approval ProcessThis 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 - April 15,2026Provided Update Drug: NKX019Announced Date: April 15, 2026Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, 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 SummaryNkarta, 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 AnnouncementPoster Presentation - October 22,2025Poster Presentation Drug: NKX019Announced Date: October 22, 2025Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced it will be presenting a poster this Sunday in Chicago at the American College of Rheumatology (ACR) Convergence 2025 meeting.AI SummaryNkarta, 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 AnnouncementEnrollment Update - December 5,2024Enrollment Update Drug: NKX019Announced Date: December 5, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, 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 SummaryNkarta, 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 AnnouncementClinical Data - December 5,2024Clinical Data Drug: NKX019Announced Date: December 5, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced that Clinical data from Ntrust-1 and Ntrust-2 planned for 2025AI SummaryNkarta, 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 AnnouncementProvided Update - July 24,2024Provided Update Drug: NKX019Announced Date: July 24, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, 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 SummaryResearchers 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 AnnouncementClinical Trial - June 27,2024Clinical Trial Drug: NKX019Announced Date: June 27, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening.AI SummaryNkarta, 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 AnnouncementClinical Data - June 27,2024Clinical Data Drug: NKX019Announced Date: June 27, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced that Clinical data from Ntrust-1 and Ntrust-2 planned for 2025AI SummaryNkarta, 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 Has Nkarta received FDA approval? As of now, Nkarta (NKTX) has not received any FDA approvals for its therapy in the last two years. What drugs has Nkarta submitted to the FDA? In the past two years, Nkarta (NKTX) has reported FDA regulatory activity for NKX019. What is the most recent FDA event for Nkarta? 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." What conditions do Nkarta's current drugs treat? Currently, Nkarta has one therapy (NKX019) targeting the following condition: Relapsed/refractory B cell malignancies. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Alterity Therapeutics FDA EventsBlack Diamond Therapeutics FDA EventsJaguar Animal Health FDA EventsLipocine FDA EventsLantern Pharma FDA EventsZenas BioPharma FDA EventsMerck & Co., Inc. FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex Therapeutics 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 Related Companies MeiraGTx FDA Events Cullinan Therapeutics FDA Events Design Therapeutics FDA Events Theravance Biopharma FDA Events Janux Therapeutics FDA Events Arbutus Biopharma FDA Events Amphastar Pharmaceuticals FDA Events Kura Oncology FDA Events Bright Minds Biosciences FDA Events Eton Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:NKTX last updated on 4/16/2026 by MarketBeat.com Staff. 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Provided Update - April 15,2026Provided Update Drug: NKX019Announced Date: April 15, 2026Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, 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 SummaryNkarta, 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
Poster Presentation - October 22,2025Poster Presentation Drug: NKX019Announced Date: October 22, 2025Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced it will be presenting a poster this Sunday in Chicago at the American College of Rheumatology (ACR) Convergence 2025 meeting.AI SummaryNkarta, 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
Enrollment Update - December 5,2024Enrollment Update Drug: NKX019Announced Date: December 5, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, 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 SummaryNkarta, 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
Clinical Data - December 5,2024Clinical Data Drug: NKX019Announced Date: December 5, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced that Clinical data from Ntrust-1 and Ntrust-2 planned for 2025AI SummaryNkarta, 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
Provided Update - July 24,2024Provided Update Drug: NKX019Announced Date: July 24, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, 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 SummaryResearchers 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
Clinical Trial - June 27,2024Clinical Trial Drug: NKX019Announced Date: June 27, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening.AI SummaryNkarta, 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
Clinical Data - June 27,2024Clinical Data Drug: NKX019Announced Date: June 27, 2024Indication: Relapsed/refractory B cell malignanciesAnnouncementNkarta, Inc. announced that Clinical data from Ntrust-1 and Ntrust-2 planned for 2025AI SummaryNkarta, 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
