Sanofi's Rilzabrutinib Receives Orphan Drug Designation in Japan
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 02 2026
0mins
Source: NASDAQ.COM
- Orphan Drug Designation: Sanofi's rilzabrutinib has received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for the treatment of IgG4-related disease, marking a significant expansion in the company's rare disease portfolio and expected to enhance market competitiveness.
- Clinical Research Progress: Rilzabrutinib is currently being evaluated in the RILIEF phase 3 study focused on IgG4-RD, and successful clinical outcomes will lay the groundwork for future market promotion and adoption.
- International Approval Status: The drug received approval for immune thrombocytopenia in the US, EU, and UAE in 2025, demonstrating broad global recognition and further strengthening Sanofi's product portfolio.
- Regulatory Review Updates: Rilzabrutinib is under regulatory review for ITP in Japan, and if approved, it will provide a new growth avenue for the company in the Japanese market, enhancing overall performance.
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Analyst Views on SNY
Wall Street analysts forecast SNY stock price to rise
5 Analyst Rating
2 Buy
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Moderate Buy
Current: 44.290
Low
57.00
Averages
79.36
High
119.07
Current: 44.290
Low
57.00
Averages
79.36
High
119.07
About SNY
Sanofi SA is a France-based healthcare company based in France. The Company focuses on patient needs and engages in the research, development, manufacture, and marketing of therapeutic solutions. Its three operating segments are: Pharmaceuticals, Consumer Healthcare (CHC), and Vaccines. The Pharmaceuticals includes: Immunology, Multiple Sclerosis / Neurology, Oncology, Rare Diseases, Rare Blood Disorders, Cardiovascular, Diabetes, Established Prescription Products. The Vaccines segment comprises, for all geographical territories, the commercial operations of Sanofi Pasteur, together with research, development, and production activities dedicated to vaccines. The CHC segment comprises the commercial operations for Sanofi’s Consumer Healthcare products, together with research, development and production activities dedicated to those products. The Company’s products developed in collaboration or franchise include Dupixent, Aubagio, Lemtrada, Cerezyme, Lumizyme, Jevtana, Fabrazyme.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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