Sanofi's Rilzabrutinib Receives Breakthrough Therapy Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 09 2026
0mins
Should l Buy SNY?
Source: seekingalpha
- Drug Certification Progress: Sanofi's rilzabrutinib has received breakthrough therapy designation in the U.S. and orphan drug status in Japan, marking a significant milestone in treating warm autoimmune hemolytic anemia, which is expected to enhance market acceptance and drive sales growth.
- Global Regulatory Status: As the first BTKi for warm autoimmune hemolytic anemia to receive FDA breakthrough therapy designation, rilzabrutinib addresses complex immune dysregulation through multi-immune modulation, showcasing its potential value across multiple rare diseases.
- Market Application Status: Rilzabrutinib is approved for immune thrombocytopenia (ITP) in the U.S., EU, and UAE, and is under regulatory review in Japan; while other indications remain investigational, the market outlook remains optimistic.
- Financial Outlook: Sanofi anticipates continued profitable growth over the next five years, with a non-GAAP EPS of €1.53 for Q4 2025, beating expectations by €0.06, and revenue of €11.3 billion, exceeding forecasts by €170 million, reflecting the company's strong financial performance.
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Analyst Views on SNY
Wall Street analysts forecast SNY stock price to rise
5 Analyst Rating
2 Buy
3 Hold
0 Sell
Moderate Buy
Current: 47.030
Low
57.00
Averages
79.36
High
119.07
Current: 47.030
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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- Significant Decrease in Hospitalizations: The study also revealed an 85.9% reduction in RSV-related lower respiratory tract infection hospitalizations during the first RSV season, alleviating the burden on healthcare systems and potentially lowering long-term medical costs associated with RSV.
- Reduction in Primary Care Consultations: Findings showed a 30.8% and 33.4% decrease in primary care consultations for acute bronchitis and lower respiratory tract infections respectively during the first RSV season, indicating that widespread vaccination may improve overall infant health outcomes.
- Substantial Decrease in Rehospitalizations: During the second RSV season, rehospitalization rates for infants previously hospitalized due to RSV decreased by 78.2%, further supporting the hypothesis that early protection can have lasting benefits on lung health, which may impact public health policy decisions.
See More
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- Vaccine Efficacy: Sanofi's Beyfortus (nirsevimab) demonstrated a statistically significant reduction in RSV-related hospitalizations during the second RSV season among infants immunized in their first season, indicating its effectiveness in preventing RSV-related diseases.
- Publication of Findings: The study results were published in The Lancet Infectious Diseases, highlighting Beyfortus's ability to maintain its immunization effects from the first season into the second, showcasing its potential for long-term protection.
- Clinical Impact: Principal investigator Federico Martinón-Torres noted that the universal immunization program with Beyfortus not only reduced hospitalization rates but also alleviated outpatient illness burden, potentially reshaping RSV vaccination strategies.
- Positive Market Reaction: Sanofi's shares were trading at 77.62 euros at the last close, reflecting investor optimism regarding the vaccine's prospects and suggesting potential market growth in the future.
See More
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- Sales Performance Fluctuations: While Sanofi's top drug Dupixent saw a 32.2% sales increase in Q4 2025, totaling €4.2 billion, vaccine sales declined by 2.5% to €2 billion, highlighting vulnerabilities in its product portfolio.
- Weak Stock Performance: Sanofi shares fell 0.68% in premarket trading to $46.71, trading 1.1% below the 20-day and 4% below the 100-day simple moving averages, indicating a bearish sentiment in the short term.
- Analyst Rating Changes: Despite an average price target of $61.50 and a “Buy” rating, recent downgrades from multiple firms suggest growing concerns about the company's future growth potential.
See More
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- Executive Transition: Sanofi has decided not to renew Paul Hudson's director mandate, with his tenure as CEO ending on February 17, 2026, marking a significant governance shift after six years of leadership.
- Succession Plan: The Board has appointed Belén Garijo as the new CEO, set to officially take over after the Group's Annual General Meeting on April 29, 2026, aiming to enhance productivity and innovation in response to external pressures.
- Sales Performance Pressure: Despite Dupixent's sales increasing by 32.2% to €4.2 billion in Q4 2025, the company faces challenges in its vaccine segment, with overall vaccine sales declining by 2.5% to €2 billion, indicating fluctuating market demand.
- Future Therapy Development: Sanofi is developing amlitelimab as a potential successor to Dupixent, with preliminary data suggesting strong prospects in treating patients aged 12 and older with moderate-to-severe atopic dermatitis, potentially providing new growth avenues for the company.
See More
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- New CEO Appointment: Belén Garijo has been appointed as the new CEO, set to officially take over after the Annual General Meeting on April 29, and her leadership is expected to bring fresh perspectives and experience, particularly in the pharmaceutical sector.
- Transition Management: Olivier Charmeil, Executive Vice President of General Medicines, will serve as Interim CEO during the transition period, ensuring operational continuity and minimizing uncertainties that may arise from the leadership change.
- Shareholder Vote: The company will hold a vote on Garijo's appointment to the Board and a proposed amendment to raise the CEO age limit, which could influence future executive selection criteria and corporate governance structures.
See More
Sanofi Board Appoints New CEO Amid Transition
- Executive Change: Sanofi's board has decided not to renew Paul Hudson's director mandate, who has served as CEO since September 2019, with his last working day set for February 17, 2026, indicating a significant leadership shift for the company.
- New CEO Appointment: Belén Garijo has been appointed as the new CEO, officially taking over after the Annual General Meeting on April 29, 2026, with her directorship subject to shareholder approval, reflecting the company's commitment to future leadership.
- Transition Arrangement: During the transition, Olivier Charmeil, the current executive vice president of general medicines, will serve as interim CEO, ensuring stability and continuity in operations during this leadership change to mitigate potential disruptions.
- Strategic Focus: As the new CEO, Garijo will concentrate on strengthening the execution of Sanofi's strategy, particularly in enhancing productivity, governance, and innovation in research and development, aiming to drive long-term growth in the competitive pharmaceutical market.
See More
