Regeneron and Sanofi Advance Kevzara Into Polymyalgia Rheumatica, Eyeing New Growth Channel
Regeneron Pharmaceuticals (REGN), Sanofi SA (SNY) announced an update on their ongoing clinical study.
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The study, titled “A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica,” will test Kevzara (sarilumab) in early polymyalgia rheumatica. It aims to show better symptom control and safety versus standard steroid taper, a key step in expanding use beyond current arthritis labels.
The trial compares two doses of sarilumab, 150 mg and 200 mg every two weeks, given as simple under-the-skin injections. Both doses are combined with a year-long prednisone taper, and results are measured against a placebo injection plus the same steroid taper, to see if Kevzara can cut flares and steroid burden.
The study is interventional and randomized, so participants are assigned by chance to sarilumab or placebo. It is double-blind with four levels of masking, meaning patients, doctors, trial staff and outcome assessors all do not know who gets active drug, and the main aim is to test treatment benefit in real-world like conditions.
The status is “not yet recruiting,” with first submission dated December 10, 2025, and the latest update filed on February 9, 2026. Primary and full completion dates are not posted, but the treatment and follow-up plan runs for about 58 weeks per patient, so investors should assume data are at least several years away from this point.
For Regeneron (REGN) and Sanofi (SNY), this Phase 4 effort signals a push to widen Kevzara’s revenue base in inflammatory disease, which could support long-term growth narratives. While near-term earnings impact is limited, a positive readout would strengthen their immunology portfolios versus peers like Roche and AbbVie, and may add support to valuation multiples if early recruitment and execution go smoothly.
The study is currently classified as not yet recruiting and has been recently updated, with further details available on the ClinicalTrials portal.
To learn more about REGN’s potential, visit the Regeneron Pharmaceuticals drug pipeline page.
