Record mula sa primary source
Decision-gradePagbabago sa trial registry
Artiva nakahanay sa FDA sa iisang Phase 3 trial para sa AlloNK sa refractory RA
Artiva nakakuha ng pagkakahanay sa FDA sa iisang Phase 3 registrational randomized controlled trial ng AlloNK kasama ang rituximab kumpara sa rituximab lamang sa ~150 refractory RA patients. Ang trial ay gagamit ng ACR50 response sa anim na buwan bilang pangunahing endpoint at planong simulan sa H2 2026. Ito ay sumusunod sa positibong Phase 2a data na nagpapakita ng 71% ACR50 response at malalim na B-cell depletion na may outpatient tolerability.
Mahahalagang fact
- Na-file
- May 8, 2026, 10:37 AM
- Kaganapan
- Pagbabago sa trial registry
- Direksyon
- Positibo
- Kumpanya
ARTVArtiva Bio- Asset
- AlloNK
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- ACR50
- 71% (5/7 pasyente)
- N ng Phase 3
- humigit-kumulang 150
- pangunahing endpoint
- ACR50 sa anim na buwan
Sipi mula sa source
EX-99.1 2 d38160dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Artiva Biotherapeutics Reports First Quarter 2026 Financial Results and Recent Business Highlights Initial AlloNK ® (AB-101) clinical data demonstrated 71% ACR50 response in refractory rheumatoid arthritis (RA) patients with at least six months of follow-up in the company-sponsored Phase 2a basket trial, with no patients relapsing or requiring new immunomodulatory agents AlloNK treatment regimen demonstrated a consistent pattern of deep B-cell depletion and tolerability results supportive of outpatient administration in community rheumatology settings U.S. Food and Drug Administration (FDA) alignment on a single Phase 3 registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approxima