Sanofi Receives FDA Approval for Wayrilz in Treating Immune Thrombocytopenia
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 01 2025
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Should l Buy SNY?
Source: NASDAQ.COM
Sanofi's FDA Approval of Wayrilz
- Approval Details: Sanofi's Wayrilz (rilzabrutinib), a novel BTK inhibitor, has received FDA approval for treating persistent or chronic immune thrombocytopenia (ITP) in adults who have not responded adequately to previous treatments. This marks Wayrilz as the first BTK inhibitor approved for ITP in the U.S.
- Clinical Study Results: The approval was based on the phase III LUNA 3 study, which demonstrated that Wayrilz significantly improved sustained platelet counts and alleviated other ITP symptoms, achieving both primary and secondary endpoints.
- Mechanism of Action: Wayrilz operates by modulating various immune pathways, addressing the root causes of ITP, and is considered potentially safer than existing treatments due to its selective BTK approach.
Patient Support and Global Expansion
- Patient Support Program: Patients prescribed Wayrilz will benefit from Sanofi’s HemAssist program, which offers comprehensive support for treatments related to rare blood disorders.
- International Review: Wayrilz is currently under review in the EU and China for ITP treatment and has already been approved in the UAE for the same condition.
Broader Development Pipeline
- Additional Indications: Beyond ITP, Wayrilz is being investigated for other rare diseases, including IgG4-related disease (IgG4-RD), for which it has received orphan drug designation from both the FDA and EMA.
- Other Conditions: The drug has also been designated for warm autoimmune hemolytic anemia (wAIHA) and sickle cell disease (SCD), with ongoing studies for wAIHA and plans for future development for SCD.
Sanofi's Market Performance
- Stock Performance: Sanofi's shares have increased by 2.6% this year, contrasting with a 0.6% decline in the broader industry.
- Zacks Rank: Sanofi holds a Zacks Rank of #3 (Hold), while competitors like Akero Therapeutics, Adaptive Biotechnologies, and Aligos Therapeutics have better rankings, indicating a more favorable outlook.
Competitor Analysis
- Akero Therapeutics: The company has seen a 67.9% stock increase year-to-date, with narrowed loss per share estimates for 2025 and 2026.
- Adaptive Biotechnologies: This firm has experienced a remarkable 119.5% stock surge year-to-date, with consistent earnings beats and improved loss estimates.
- Aligos Therapeutics: In contrast, Aligos has faced a 73.7% decline in stock value this year, with mixed earnings results and negative surprises.
Investment Insights
- Future Stock Recommendations: Zacks Investment Research has identified five stocks with high potential for significant gains, including a satellite-based communications firm expected to thrive in the burgeoning trillion-dollar space industry.
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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.
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- 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.
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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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- Leadership Transition: Sanofi announced that CEO Paul Hudson will depart on February 17, with Belén Garijo succeeding him, reflecting ongoing challenges in the company's drug pipeline and market performance, which may impact investor confidence.
- 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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- Executive Change: Sanofi's Board of Directors has decided not to renew CEO Paul Hudson's mandate, with his last day set for February 17, indicating a significant leadership shift that may impact the company's strategic direction.
- 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
