TOKYO AND PRINCETON, Japan and the U.S., March 03, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, today announced the discontinuation of all ongoing clinical trials for rocatinlimab, an investigational anti-OX40 monoclonal antibody being evaluated for potential indications in moderate-to-severe atopic dermatitis, prurigo nodularis, and moderate-to-severe asthma.

The most recent safety review conducted over the last several weeks identified emerging concerns of malignancies with possible viral or immune-related links. This included one new confirmed case and one suspected case of Kaposi’s sarcoma, in addition to the previously confirmed case, suggesting a potential mechanistic link to OX40 pathway modulation. While the overall number of malignancy cases across the program remains below expected background rates, the characteristics of these cases raise a plausible biological concern that cannot be excluded.

Kyowa Kirin at: www.KyowaKirin.com

Kyowa Kirin Announces Discontinuation of Rocatinlimab Clinical Trials due to Risk of Malignancy