Sanofi SA ((SNY)), Sanofi ((SNYNF)), Sanofi ((DE:SNW)) announced an update on their ongoing clinical study.
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Sanofi SA has launched a Phase 3 clinical study titled A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis. The study aims to assess the efficacy of frexalimab in delaying disability progression in adults with nonrelapsing secondary progressive multiple sclerosis (nrSPMS) and to evaluate its safety over a 36-month period.
The study is testing frexalimab, an intravenous drug, against a placebo. Frexalimab is designed to be administered via IV infusion, along with MRI contrast-enhancing agents, to determine its effectiveness in treating nrSPMS.
This interventional study is randomized with a parallel assignment model and employs quadruple masking to ensure unbiased results. The primary purpose is treatment-focused, aiming to provide insights into the potential benefits of frexalimab.
The study officially started on December 27, 2023, with an expected duration of 43 months, concluding when the target number of 6-month confirmed disability progression events is achieved. The last update was submitted on July 1, 2025, indicating ongoing recruitment and data collection.
The outcome of this study could significantly impact Sanofi’s market position, potentially boosting investor confidence and affecting stock performance positively if results show frexalimab’s efficacy. This development is crucial as it positions Sanofi competitively within the multiple sclerosis treatment market.
The study is currently ongoing, with further details available on the ClinicalTrials portal.