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Sanofi Ends Late-Stage Study on Neurology Drug Over Weak Results
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Key Takeaways
Sanofi discontinued the phase III MOBILIZE study of riliprubart in refractory CIDP patients.
An interim analysis found riliprubart unlikely to provide sufficient efficacy; no new safety issues emerged.
Sanofi will assess ongoing riliprubart studies, including the phase III VITALIZE study in CIDP.
Sanofi (SNY - Free Report) announced that it is discontinuing the phase III MOBILIZE study, which is evaluating its investigational drug, riliprubart, in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care (SoC) treatment.
This decision comes after an independent committee conducted an interim analysis of the data from the MOBILIZE study and concluded that riliprubart was “unlikely to provide sufficient efficacy” in this difficult-to-treat patient population. The analysis did not identify any new safety concerns associated with the drug.
With this setback, Sanofi stated that it will assess the future of other ongoing riliprubart studies, including the phase III VITALIZE study in CIDP patients receiving maintenance intravenous immunoglobulin (IVIg) therapy.
CIDP is a rare disorder affecting the peripheral nervous system, marked by progressive muscle weakness and sensory loss.
SNY’s Stock Performance
Following this announcement, Sanofi's shares were trading lower in pre-market trading today. While the company assured investors that the MOBILIZE study termination does not affect its financial outlook for 2026, the setback raises concerns about the future of riliprubart, which was previously viewed as one of its promising pipeline candidates.
Sanofi had previously outlined plans for a regulatory filing in 2027 based on data from the MOBILIZE and VITALIZE studies. The drug has also secured orphan drug designation in both the United States and Europe for CIDP. Although VITALIZE remains ongoing, the loss of one pivotal study raises uncertainty about riliprubart's regulatory and commercial prospects.
Year to date, the stock has lost nearly 8% against the industry’s 4% growth.
Image Source: Zacks Investment Research
More on Sanofi’s Riliprubart
An investigational IgG4 humanized monoclonal antibody, riliprubart, is designed to selectively inhibit activated C1s in the classical complement pathway of the innate immune system.
Apart from CIDP, Sanofi is assessing riliprubart in a phase II study for antibody-mediated rejection (AMR) in kidney transplant recipients. The study is evaluating the drug in patients at risk of developing AMR as well as those with active AMR, reflecting the company's efforts to explore the therapy's potential across multiple immune-mediated diseases.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost 18% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up nearly 7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
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Sanofi Ends Late-Stage Study on Neurology Drug Over Weak Results
Key Takeaways
Sanofi (SNY - Free Report) announced that it is discontinuing the phase III MOBILIZE study, which is evaluating its investigational drug, riliprubart, in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care (SoC) treatment.
This decision comes after an independent committee conducted an interim analysis of the data from the MOBILIZE study and concluded that riliprubart was “unlikely to provide sufficient efficacy” in this difficult-to-treat patient population. The analysis did not identify any new safety concerns associated with the drug.
With this setback, Sanofi stated that it will assess the future of other ongoing riliprubart studies, including the phase III VITALIZE study in CIDP patients receiving maintenance intravenous immunoglobulin (IVIg) therapy.
CIDP is a rare disorder affecting the peripheral nervous system, marked by progressive muscle weakness and sensory loss.
SNY’s Stock Performance
Following this announcement, Sanofi's shares were trading lower in pre-market trading today. While the company assured investors that the MOBILIZE study termination does not affect its financial outlook for 2026, the setback raises concerns about the future of riliprubart, which was previously viewed as one of its promising pipeline candidates.
Sanofi had previously outlined plans for a regulatory filing in 2027 based on data from the MOBILIZE and VITALIZE studies. The drug has also secured orphan drug designation in both the United States and Europe for CIDP. Although VITALIZE remains ongoing, the loss of one pivotal study raises uncertainty about riliprubart's regulatory and commercial prospects.
Year to date, the stock has lost nearly 8% against the industry’s 4% growth.
Image Source: Zacks Investment Research
More on Sanofi’s Riliprubart
An investigational IgG4 humanized monoclonal antibody, riliprubart, is designed to selectively inhibit activated C1s in the classical complement pathway of the innate immune system.
Apart from CIDP, Sanofi is assessing riliprubart in a phase II study for antibody-mediated rejection (AMR) in kidney transplant recipients. The study is evaluating the drug in patients at risk of developing AMR as well as those with active AMR, reflecting the company's efforts to explore the therapy's potential across multiple immune-mediated diseases.
SNY’s Zacks Rank
Sanofi currently carries a Zacks Rank #3 (Hold).
Sanofi Price
Sanofi price | Sanofi Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Immunocore (IMCR - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost 18% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up nearly 7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.