Artiva Biotherapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Artiva Biotherapeutics (ARTV).
Over the past two years, Artiva Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AlloNK®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AlloNK® + rituximab FDA Regulatory Timeline and Events
AlloNK® + rituximab is a drug developed by Artiva Biotherapeutics for the following indication: For the treatment of B-cell driven diseases.
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:
- AlloNK® + rituximab
- Announced Date:
- May 8, 2026
- Indication:
- For the treatment of B-cell driven diseases
Announcement
Artiva Biotherapeutics, Inc. announced positive initial clinical data from ongoing clinical trials evaluating AlloNK® (also known as AB-101) in combination with rituximab.
AI Summary
Artiva Biotherapeutics reported positive initial clinical data for AlloNK (AB-101) given with rituximab in autoimmune trials. In a company-sponsored Phase 2a basket trial, refractory rheumatoid arthritis patients showed a 71% ACR50 response at six months of follow-up, with no patients relapsing or needing new immunomodulatory drugs. AlloNK plus rituximab was well tolerated in outpatient community rheumatology settings: no cytokine release syndrome (CRS), no ICANS, and no treatment discontinuations were observed.
More than 70 autoimmune patients have been treated with AlloNK across over 40 mostly community sites, supporting a planned registrational trial expected to start in the second half of 2026. Data also showed deep B‑cell depletion and reconstitution consistent with the proposed mechanism, plus early responses in Sjögren disease and systemic sclerosis, suggesting broader potential across B‑cell‑driven autoimmune diseases. A two-dose AlloNK regimen with conditioning and rituximab is being proposed for the next trial.
Read Announcement- Drug:
- AlloNK® + rituximab
- Announced Date:
- November 12, 2025
- Indication:
- For the treatment of B-cell driven diseases
Announcement
Artiva Biotherapeutics, Inc. announced positive initial safety and translational data from ongoing clinical trials of AlloNK® (also known as AB-101) in combination with rituximab or obinutuzumab for the treatment of autoimmune disease.
AI Summary
Artiva Biotherapeutics reported positive initial safety and translational data for AlloNK (AB-101) given with rituximab or obinutuzumab in autoimmune disease. As of the October 1, 2025 cutoff, 32 patients across diseases including refractory rheumatoid arthritis, Sjögren’s, lupus and systemic sclerosis received outpatient treatment (1 billion or 4 billion cells per dose), mostly at community rheumatology sites. This shows the regimen can be delivered outside hospital oncology units.
The treatment was generally well tolerated: most side effects were temporary Grade 1–2 and consistent with the cyclophosphamide/fludarabine conditioning. There were no AlloNK-related Grade 3+ adverse events, no cytokine release syndrome (CRS), no ICANS, no graft-versus-host disease, and no hypogammaglobulinemia. One unrelated hospitalization for skin infection was reported.
Translational results showed deep B‑cell depletion: all 23 patients with samples had non‑quantifiable peripheral CD19+ B cells by Day 13, confirmed by a high‑sensitivity assay. Reconstituted B cells in four patients were mainly naïve and transitional. Artiva expects to share initial clinical response data and engage with the FDA on pivotal trial design in the first half of 2026.
Read Announcement- Drug:
- AlloNK® + rituximab
- Announced Date:
- May 13, 2025
- Indication:
- For the treatment of B-cell driven diseases
Announcement
Artiva Biotherapeutics, I announced new longer-term Phase 1/2 data demonstrating durable responses for AlloNK® (also known as AB-101) in combination with rituximab (RTX) in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) at the American Society of Gene & Cell Therapy (ASGCT) 28th annual meeting.nc
AI Summary
Artiva Biotherapeutics announced new longer-term Phase 1/2 data at the ASGCT 28th annual meeting demonstrating durable responses using AlloNK® (also called AB-101) combined with rituximab (RTX) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. In this heavily pretreated patient group, which had not received prior CAR-T cell therapy, the combination achieved a 64% complete response rate. The median duration of response has not yet been reached, with data showing it is at least 19.4 months. These impressive results are in line with outcomes seen in approved auto-CAR-T therapies for aggressive B-NHL. The findings support AlloNK’s strong potential to enhance the effectiveness of standard monoclonal antibodies by delivering deep and lasting B-cell depletion, offering hope for improved treatment in challenging cancer and autoimmune disease settings.
Read Announcement- Drug:
- AlloNK® + rituximab
- Announced Date:
- April 28, 2025
- Indication:
- For the treatment of B-cell driven diseases
Announcement
Artiva Biotherapeutics, Inc announced that the Company will have a poster presentation on new longer-term Phase 1/2 data for AlloNK® (also known as AB-101) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma at the upcoming American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting taking place May 13-17, 2025, in New Orleans, Louisiana.
AI Summary
Artiva Biotherapeutics, Inc. announced that it will present new longer-term Phase 1/2 data on AlloNK® (also known as AB-101) at the upcoming American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting in New Orleans, Louisiana, from May 13–17, 2025. The poster presentation (Abstract 858) will share data from patients with relapsed or refractory B-cell non-Hodgkin lymphoma, showing a prolonged response, deep B-cell depletion, and a well-tolerated safety profile for AlloNK® when combined with rituximab. In addition, Artiva will feature another poster (Abstract 1765) that highlights the scalability and consistency of the company’s AlloNK manufacturing process. These sessions aim to demonstrate the potential of AlloNK® as a novel treatment option for challenging B-cell driven diseases, reflecting the company’s commitment to developing effective and accessible cell therapies.Read Announcement
Artiva Biotherapeutics FDA Events - Frequently Asked Questions
As of now, Artiva Biotherapeutics (ARTV) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Artiva Biotherapeutics (ARTV) has reported FDA regulatory activity for AlloNK® + rituximab.
The most recent FDA-related event for Artiva Biotherapeutics occurred on May 8, 2026, involving AlloNK® + rituximab. The update was categorized as "Positive Data," with the company reporting: "Artiva Biotherapeutics, Inc. announced positive initial clinical data from ongoing clinical trials evaluating AlloNK® (also known as AB-101) in combination with rituximab."
Currently, Artiva Biotherapeutics has one therapy (AlloNK® + rituximab) targeting the following condition: For the treatment of B-cell driven diseases.
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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:ARTV last updated on 5/8/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
