Agios Enters Exclusive Global License Agreement with Oscotec to Develop and Commercialize Next-Generation SYK Inhibitor Cevidoplenib
View original at globenewswire.comAgios Enters Exclusive Global License Agreement with Oscotec to Develop and Commercialize Next-Generation SYK Inhibitor Cevidoplenib Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocy…
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Agios expects to advance cevidoplenib into Phase 3 development for ITP in the first half of 2028, following completion of additional chemistry, manufacturing, and controls (CMC) development work.
60% confidenceLicensing cevidoplenib is a natural extension of Agios' therapeutic focus and expertise, expanding and diversifying the rare hematology portfolio into ITP, and aligns with the company's disciplined approach to capital allocation.
60% confidenceThe Phase 2 primary endpoint did not achieve statistical significance, but durable and clinically meaningful platelet responses were observed in the cevidoplenib arm compared with placebo across multiple secondary endpoints; cevidoplenib was well tolerated.
60% confidenceThe license agreement unlocks up to $1 billion in peak U.S. sales potential for cevidoplenib.
60% confidenceThe most commonly reported treatment-related adverse events with cevidoplenib in Phase 2 included transient elevations in liver enzymes and gastrointestinal events, and no new safety signals were identified.
60% confidenceGlobally, ITP affects an estimated 200,000 individuals, including 90,000 adults diagnosed in the U.S., of whom roughly 50,000 have chronic ITP requiring treatment, and approximately 24,000 do not respond to initial treatments.
60% confidenceCevidoplenib is a next-generation SYK inhibitor uniquely designed to potentially offer improved tolerability and durability compared to first-generation SYK inhibitors; backed by clinically meaningful Phase 2 data, it has the opportunity to become a best-in-class treatment option for ITP.
60% confidenceAgios continues to expect its 2026 operating expense guidance to be approximately flat compared to 2025, excluding the $25.0 million upfront payment to Oscotec.
60% confidence