Kyowa Kirin Takes Full Global Control of Rocatinlimab After Amgen Exit

Kyowa Kirin Co., Ltd. has announced the termination of its development and commercialization collaboration with Amgen for rocatinlimab, following a strategic portfolio prioritization by Amgen. Going forward, Kyowa Kirin will assume full global responsibility for the rocatinlimab program, including regulatory filings and future commercialization.

The two companies are coordinating a smooth and orderly transition, with a stated focus on ensuring continuity for patients currently enrolled in clinical trials. Amgen, which has partnered with Kyowa Kirin for more than four decades, will continue to manufacture rocatinlimab.

Rocatinlimab is being developed for the treatment of moderate-to-severe atopic dermatitis. Kyowa Kirin leadership reaffirmed confidence in the asset, highlighting its differentiated mechanism of action targeting the OX40 receptor and its potential to deliver durable disease control in a condition characterized by chronic and unpredictable flares.

In November 2025, pivotal Phase 3 results from the ROCKET-IGNITE and ROCKET-HORIZON studies were published in The Lancet. Across nearly 1,500 adult patients, rocatinlimab monotherapy met all co-primary and key secondary endpoints, including the revised Investigator’s Global Assessment score of 0 or 1, a key requirement for U.S. regulatory submission. The trials demonstrated clear or almost clear skin with stringent criteria applied to residual disease signs.

Additional support comes from the long-term safety extension study, ASCEND. Previously disclosed topline data suggested sustained therapeutic effects with extended dosing. The safety profile was consistent with earlier ROCKET studies, with the most common treatment-emergent adverse events including upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis. Full results from ASCEND are expected to be presented at an upcoming medical meeting.

Rocatinlimab originated from Kyowa Kirin’s internal research, reflecting the company’s long-standing focus on immunology and antibody engineering. The broader Phase 3 ROCKET program comprises eight pivotal studies and has enrolled more than 3,300 patients, including adults and adolescents, treatment-naïve patients, and those previously exposed to biologics or JAK inhibitors. This breadth is intended to position rocatinlimab for use across a wide range of real-world clinical settings.

Kyowa Kirin plans to submit its first regulatory application in the United States, followed by Japan, with additional global markets to follow as appropriate. The company views rocatinlimab as a core strategic priority as it advances toward potential approval and commercialization.

Reference

Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis, 30 January 2026, Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program, Demonstrating Strong Commitment to Address High Unmet Medical Need in Atopic Dermatitis

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) (ROCKET-Ignite), ClinicalTrials.gov ID NCT05398445, https://clinicaltrials.gov/study/NCT05398445

Guttman-Yassky, Emma et al., Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials, The Lancet, Volume 407, Issue 10523, 53 – 66, https://doi.org/10.1016/S0140-6736(25)01865-3

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon), ClinicalTrials.gov ID NCT05651711, https://clinicaltrials.gov/study/NCT05651711