FDA Events for Artiva Biotherapeutics (ARTV)
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 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 13, 2025, involving AlloNK® + rituximab. The update was categorized as "Data," with the company reporting: "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"
Currently, Artiva Biotherapeutics has one therapy (AlloNK® + rituximab) targeting the following condition: For the treatment of B-cell driven 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:ARTV) was last updated on 7/13/2025 by MarketBeat.com Staff
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