Sanofi Halts Phase III Trials for Neurology Drug Due to Inconclusive Outcomes

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Sanofi (SNY) announced the discontinuation of its phase III MOBILIZE study for the experimental drug riliprubart, aimed at treating patients with chronic inflammatory demyelinating polyneuropathy (CIDP) resistant to standard care. This decision follows an interim analysis by an independent committee, which determined that riliprubart is “unlikely to provide sufficient efficacy” in this challenging patient cohort. No new safety concerns were identified.

Following the announcement, Sanofi’s shares traded lower in pre-market activity. The company stated that the termination of the MOBILIZE study would not impact its financial outlook for 2026, yet concerns about riliprubart’s future prospects have intensified. Sanofi had previously intended to file for regulatory approval in 2027 based on data from both the MOBILIZE and an ongoing phase III study called VITALIZE, which continues in CIDP patients receiving intravenous immunoglobulin therapy.

CIDP is a rare disorder of the peripheral nervous system, leading to muscle weakness and sensory loss. The market reaction has raised uncertainties about the commercial viability and regulatory future of riliprubart, which had previously received orphan drug designation in both the U.S. and Europe.

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