Regeneron and Sanofi Extend Phase 3 Itepekimab Program in Chronic Sinus Disease
Regeneron Pharmaceuticals (REGN), Sanofi SA (SNY) announced an update on their ongoing clinical study.
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The study “A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps” follows patients from two prior trials. It aims to track long term safety, side effects, and sustained benefit of itepekimab in a hard to treat sinus disease.
The treatment is itepekimab, also known as SAR440340 or REGN3500, given as an under the skin injection. The study compares a higher dose and a lower dose, with placebo used in the low dose arm, to see how much drug patients need for durable relief and acceptable safety.
This is a Phase 3 interventional trial with patients randomly assigned to one of two treatment arms. It is triple blinded, so patients, their doctors, and study staff do not know which dose is used, and the main goal is to measure safety while also tracking longer term effectiveness.
The trial can last up to 72 weeks for each patient, with 52 weeks of treatment and 20 weeks of follow up. Key timing markers include the initial submission on Feb. 13, 2026, and the most recent update on Mar. 13, 2026, which signals active operational progress for this extension study.
For investors in Sanofi (SNY) and Regeneron (REGN), this update reinforces the companies’ push in inflammatory diseases beyond asthma and atopic dermatitis. If itepekimab shows strong long term safety and sustained benefit, it could support a multi indication franchise and compete with current biologics, which may improve sentiment and support valuation multiples over time.
The study remains active and updated, with more detailed information available on the ClinicalTrials portal.
To learn more about REGN’s potential, visit the Regeneron Pharmaceuticals drug pipeline page.
