ARTIVA BIOTHERAP.DL-,0001 Aktie

Artiva Biotherapeutics announced the start of a randomized Phase III trial of its allogeneic NK‑cell therapy AlloNK, to be tested against rituximab with results expected to be evaluated by the end of 2028. Phase II data in 7 evaluable RA patients showed an ACR50 response rate of 71% at six months; the company highlights deep B‑cell depletion measured by a proprietary assay. Artiva reports $300 million in capital, sufficient to fund the program through 2029, and emphasizes a favorable safety profile without CRS or ICANS that could allow administration in outpatient clinics. The planned study will enroll 150 patients across more than 80 sites; the primary endpoint is ACR50 at six months. » Więcej na de.investing.com

At the Cantor Fitzgerald Healthcare Conference, Artiva Biotherapeutics reported progress on its AlloNK program for deep B‑cell depletion in refractory rheumatoid arthritis and announced plans to move toward a regulatory‑relevant phase III trial. The phase II study has enrolled more than 70 patients; initial interim data show increasing efficacy between months three and six and ACR50 response rates in rituximab‑refractory patients. Phase III activation is planned before the end of 2024 with top‑line results expected by the end of 2028; management says funding is sufficient through 2029 but notes caveats regarding Cy/Flu preconditioning and a longer regulatory pathway. Artiva positions the program as a differentiated approach versus other NK and CAR‑T therapies and is considering follow‑on indications such as Sjögren’s syndrome and scleroderma. » Więcej na de.investing.com

Artiva has initiated a randomized, controlled phase‑3 trial of about 150 patients testing AlloNK in combination with rituximab versus rituximab alone. The primary endpoint is ACR50 response at six months; Artiva is targeting a response rate above 50% versus an expected ~20% with rituximab alone. The FDA agreed to a single pivotal study; topline results are expected by the end of 2028, and site activation and patient recruitment are planned to begin in the second half of 2026. Artiva also plans to present updated phase‑2a data in H2 2026 and says it has funding secured through 2029. » Więcej na de.investing.com