US EditionKyowa Kirin Takes Full Control of Rocatinlimab Program
Kyowa Kirin will file for U.S. regulatory approval in 2026 after Phase 3 success, ending its partnership with Amgen who will continue manufacturing rocatinlimab.
- On Jan. 30, 2026, Kyowa Kirin Co., Ltd. announced it is ending its collaboration with Amgen and regaining control of the global rocatinlimab program.
- Because Amgen reprioritized its portfolio, it ended the collaboration as a strategic portfolio prioritization despite Phase 3 ROCKET-IGNITE and ROCKET-HORIZON findings published in The Lancet with more than 3,300 patients enrolled.
- Results show the ROCKET trials met regulatory endpoints, with ROCKET-IGNITE and ROCKET-HORIZON meeting the rIGA 0/1 requirement, and the ROCKET-ASCEND study demonstrated sustained effect.
- Amgen will continue manufacturing rocatinlimab while the companies initiate a smooth transition ensuring continuity for clinical trial participants.
- Rocatinlimab's differentiated anti-OX40 approach positions it as a potentially first-and-only T-cell rebalancing therapy targeting the OX40 receptor, including adults and adolescents and studied in asthma and prurigo nodularis with results at upcoming medical congresses.
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12 Articles
Globe Newswire
Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis
Kyowa Kirin affirms commitment to developing rocatinlimab as a life-changing differentiated asset with significant market potential.Rocatinlimab’s novel...
Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis - Swaziland Online News
Kyowa Kirin affirms commitment to developing rocatinlimab as a life-changing differentiated asset with significant market potential. Rocatinlimab’s novel approach as an investigational T-cell rebalancing therapy directly targeting the OX40 receptor expressed on pathogenic T-cells shows potential to deliver long-term disease control in patients with moderate-to-severe atopic dermatitis (msAD). Regulatory submission is planned in the first […] The…
Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis - Cape Verde Wire
Kyowa Kirin affirms commitment to developing rocatinlimab as a life-changing differentiated asset with significant market potential. Rocatinlimab’s novel approach as an investigational T-cell rebalancing therapy directly targeting the OX40 receptor expressed on pathogenic T-cells shows potential to deliver long-term disease control in patients with moderate-to-severe atopic dermatitis (msAD). Regulatory submission is planned in the first […]
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