Kyowa Kirin Co., Ltd. (KYKOY) said on Friday it has ended its development and commercialization partnership with Amgen for rocatinlimab, with the Japanese drugmaker regaining full control of the drug's development. The decision follows a strategic portfolio review by Amgen.
In November 2025, results from the Phase 3 ROCKET-IGNITE and ROCKET-HORIZON studies were published in The Lancet. Both trials met all co-primary and key secondary endpoints, including U.S. regulatory submission requirements, showing significant skin clearance benefits. Long-term data from the ROCKET-ASCEND extension study also demonstrated durable efficacy and extended dosing potential.
Kyowa Kirin said Amgen will continue to manufacture rocatinlimab.
The companies had signed a collaboration agreement in 2021 to jointly develop and commercialise rocatinlimab for atopic dermatitis, with potential use in other autoimmune diseases.
Kyowa Kirin said rocatinlimab remains a key strategic priority and expressed confidence in its potential to treat moderate-to-severe atopic dermatitis, citing its differentiated mechanism of action targeting the OX40 receptor.
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