Regeneron Advances Phase 3 ROXI-CAT-II Trial, Targeting Safer Cancer-Related Clot Treatment
Regeneron Pharmaceuticals (REGN) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals, Inc. (REGN) is running a large Phase 3 study called “A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508… (ROXI-CAT-II).” The goal is to test a new blood thinner in adults with cancer who have dangerous blood clots, aiming to improve treatment and long-term prevention of repeat events.
The main drug is REGN7508, also known as cenvacibart, a lab-made antibody that targets Factor XI in the clotting system. It is designed to prevent and treat blood clots while trying to reduce bleeding risk versus current standard pills.
The study compares REGN7508 with apixaban, a well-known oral blood thinner that serves as the active control. It looks at how well REGN7508 treats clots and stops new ones, as well as side effects, drug levels in blood, and whether patients develop antibodies that could weaken the drug.
The trial is randomized and uses a parallel design, meaning patients are assigned to one of the two treatments and stay on that path. It is open-label, so both doctors and patients know which drug is used, and the main purpose is treatment rather than prevention in healthy subjects.
The study is listed as recruiting, signalling active site start-up and enrollment. The initial submission date is March 5, 2026, with the latest update filed on May 26, 2026, which tells investors the protocol and timelines are current, though primary and final completion dates are not yet posted.
For investors, this program underpins Regeneron’s push into cardiovascular and thrombosis markets beyond its core eye and immunology drugs. A positive outcome against apixaban could support a premium valuation for REGN7508 and open a new multi-billion dollar segment where competitors like Eliquis and other Factor Xa drugs now dominate.
At this early stage, the update mainly supports confidence in pipeline momentum and long-term growth, rather than near-term revenue. If recruitment is smooth and safety is clean, sentiment on REGN may strengthen as investors see optionality in oncology-related clot care and potential future use in broader VTE populations.
The ROXI-CAT-II study of REGN7508 is ongoing and recently updated, with further operational details available on the ClinicalTrials portal.
To learn more about REGN’s potential, visit the Regeneron Pharmaceuticals drug pipeline page.
