Amgen Inc. and its partner Kyowa Kirin announced that they are stopping all clinical trials of the anti‑OX40 antibody rocatinlimab after a safety review identified emerging malignancy signals, including cases of Kaposi’s sarcoma.
Rocatinlimab had been in late‑stage development for moderate to severe atopic dermatitis, prurigo nodularis, and asthma. The decision removes a late‑stage candidate from Amgen’s oncology and immunology pipeline, a significant setback for a program that had advanced to multiple indications.
Amgen had previously exited the partnership in February 2026 as part of a strategic portfolio review. The halt follows a safety review that identified malignancy signals, prompting the companies to prioritize patient safety and regulatory compliance.
Amgen’s Q4 2025 earnings, released February 3 2026, showed revenue of $9.9 billion, up 9% year‑over‑year, and non‑GAAP EPS of $5.29, beating analyst estimates. The company had guided 2026 revenue between $37.0 billion and $38.4 billion. While the rocatinlimab halt may reduce future pipeline depth, it is unlikely to materially impact the company’s current financials.
Amgen’s stock fell 3.08% on March 5 2026, following an analyst downgrade to Hold and a cautious 2026 outlook. The decline was driven by concerns over biosimilar competition, margin erosion, and decelerating growth, rather than the trial halt alone.
Kyowa Kirin President Abdul Mullick said, "This is deeply disappointing news, as we had hoped to bring a safe and effective treatment to patients. Rocatinlimab has demonstrated durable and clinically meaningful efficacy in moderate to severe atopic dermatitis in the ROCKET program. However, the safety profile has evolved, and as patient safety remains our highest priority, we have taken this decisive and cautious step."
The halt signals a broader shift in Amgen’s pipeline strategy, focusing on assets with clearer risk‑benefit profiles. The company remains committed to its core portfolio, with strong performers such as Repatha, Evenity, and Tezspire driving growth.
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