Amgen has terminated its rocatinlimab collaboration with Kyowa Kirin, walking away from the anti-OX40 antibody five years after paying $400 million for rights to the autoimmune disease drug candidate.
The partners tested rocatinlimab in a vast R&D program, running eight phase 3 trials in atopic dermatitis alone, but the readouts left questions about the positioning of the asset in a competitive space. While rocatinlimab beat placebo, unfavorable comparisons to Sanofi and Regeneron’s juggernaut Dupixent left William Blair analysts seeing “a moderate commercial opportunity” as a later-line therapy.
Amgen has opted not to pursue that opportunity, freeing itself from up to $850 million in regulatory and commercial milestones in the process. Kyowa attributed the decision to Amgen's strategic portfolio prioritization.
The decision deprives Amgen of a potential growth driver that it could have strengthened through label expansions over time. Kyowa plans to file for FDA approval in atopic dermatitis in the first half of 2026. A phase 3 trial in prurigo nodularis is set to wrap up around the end of 2026, according to the federal trials database.
Guggenheim Securities analysts expect phase 2 rocatinlimab asthma data in late 2026 or early 2027. The analysts named the readout as one of their four most highly anticipated upcoming events at Amgen in a recent note to investors.
Signs that Amgen was cooling on rocatinlimab emerged last year. Asked about the market positioning of the antibody at a Citi event in December, Kave Niksefat, senior vice president for global marketing and access at Amgen, opted against delivering a full-throated show of faith in the program’s prospects.
“We’re evaluating the totality of that data in a very competitive atopic dermatitis market, and we'll have further discussions and announcements regarding filing plans in due course,” Niksefat said.
Amgen’s decision follows the publication of data on Sanofi’s rival OX40 drug candidate amlitelimab. The first phase 3 data on the asset disappointed investors last year. Like Amgen, Sanofi was hit by unfavorable cross-trial comparisons to Dupixent. The subsequent failure of analyses run to support filings in Europe dealt another blow, but Sanofi is pushing ahead with plans to seek approvals this year.