Amgen announced the termination of its collaboration with Kyowa Kirin for the rocatinlimab program, an anti‑OX40 monoclonal antibody aimed at moderate‑to‑severe atopic dermatitis. The decision ends a partnership that began in June 2021 and involved a $400 million upfront payment from Amgen and up to $850 million in milestone payments.
Under the termination, Kyowa Kirin regains global rights to rocatinlimab, including regulatory filings and future commercialization. Amgen will continue to manufacture the antibody, ensuring a smooth transition for patients and regulators.
The move follows mixed results from Phase 3 trials that compared rocatinlimab to Dupixent, the market leader. While rocatinlimab met primary endpoints in a subset of patients, overall efficacy was lower than expected and safety signals—particularly increased eczema flare‑ups—raised concerns. The data did not provide a clear advantage over existing therapies, prompting Amgen to reassess the program’s commercial viability.
Amgen’s leadership cited strategic portfolio prioritization as the reason for the exit. “We are focusing on assets with higher upside, such as our obesity and oncology pipelines,” said Senior Vice President for Global Marketing and Access, Kave Niksefat. The decision frees up potential milestone payments of up to $850 million, allowing the company to invest in high‑growth areas.
Kyowa Kirin plans to file for FDA approval in the first half of 2026 and will pursue commercialization in the U.S. and Europe. The company believes rocatinlimab’s unique mechanism—targeting the OX40 receptor to modulate T‑cell activity—offers a differentiated option for patients who do not respond to existing biologics.
The termination reflects broader market dynamics in the atopic dermatitis space, where Dupixent and other biologics maintain strong market share. Amgen’s exit signals a shift away from the OX40 pathway, which has faced competitive pressure and uncertain clinical benefit across indications.
Analysts note that the decision aligns with Amgen’s recent financial performance, which saw Q4 2025 revenue of $7.1 billion and a net income of $1.2 billion, underscoring the company’s focus on high‑margin growth assets.
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