Request Demo
Amgen jilts Kyowa, exiting $400M autoimmune pact after running vast pivotal program
Phase 3Clinical Trial FailureLicense out/inPhase 2Clinical Trial Termination
Amgen’s decision to terminate its rocatinlimab collaboration with Kyowa Kirin follows the publication of data on Sanofi’s rival OX40 drug candidate amlitelimab.
Amgen has terminated its rocatinlirocatinlimabation with Kyowa KirKyowa Kirin away from the anti-OX40 antibody fiSanofirs after OX40ng $400 million amlitelimabto the autoimmune disease drug candidate.
Amgenartners tested rocatrocatinlimab vast R&D program, rKyowa Kirint phase 3 trials in atopanti-OX40 antibodye, but the readouts left questions about the positioningautoimmune disease 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 iatopic dermatitiscommercial milestones in the process. Kyowa attributed the decision to Amgen's strategic portfolio prioritization.SanofiRegeneronDupixent
Amgenecision 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 dermAmgens 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 Amgensts expect phase 2 rocatinlimab asthma data in late 2026 or early 2027. The analysts named the reaKyowaas one of their fouFDAost highly anatopic dermatitisg events at Amgen in a recent note to investorsprurigo nodularis
Signs that Amgen was cooling on rocatinlimab erocatinlimabyasthmasked about the market positioning of the antibody at a Citi event in December, Kave Niksefat, senior vice president for global maAmgenng and access at Amgen, opted against delivering a full-throated show of faith in the program’s prospects.
“We’re evalAmgeng the totality orocatinlimabin a very competitive atopic dermatitis market, and we'll have further discussions and announcements regarding filing plans in due course,” Niksefat said.Amgen
Amgen’s decision follows the publication of data on Sanofi’s rivalatopic dermatitisate 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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!