ARTIVA BIOTHERAP.DL-,0001 Aktie

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. » Plus sur 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. » Plus sur de.investing.com

Artiva Biotherapeutics presented its allogeneic NK-cell therapy AlloNK and reported an ACR50 response rate of 71% in 21 therapy-refractory rheumatoid arthritis patients. The company reports no CRS and no ICANS in the safety database and considers the profile suitable for office-based practices. The FDA agreed to a Phase III design with about 150 patients (2:1 randomization, primary endpoint ACR50 at six months); Artiva expects study readout in 2028 and financial runway through 2029. A parallel basket study is underway in Sjögren’s, sclerosis and myositis; projected manufacturing costs are about $8,000 per treatment. » Plus sur de.investing.com