Sanofi's Venglustat Drug Meets Primary Endpoints in Gaucher Disease Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6d ago
0mins
Should l Buy SNY?
Source: NASDAQ.COM
- Clinical Trial Success: Sanofi's Venglustat met all primary endpoints in the phase 3 LEAP2MONO study for Gaucher disease, demonstrating statistically significant improvements in neurological symptoms at week 52, indicating the drug's substantial potential in treating Gaucher disease.
- Safety Profile: In the trial, Venglustat performed comparably to enzyme replacement therapy (ERT) on non-neurological outcomes, successfully meeting three key secondary endpoints, including changes in spleen and liver volumes and hemoglobin levels, showcasing its safety and efficacy.
- Global Regulatory Filing Plans: Sanofi plans to pursue global regulatory filings for Venglustat in the treatment of Gaucher disease, reflecting the company's confidence in the drug's market prospects and its aim to address critical unmet medical needs for patients.
- Fabry Disease Study Results Underwhelming: In the phase 3 PERIDOT study for Fabry disease, Venglustat did not demonstrate superiority on the primary endpoint, although both groups experienced pain reduction, with further data analysis expected to provide more insights at future medical meetings.
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Analyst Views on SNY
Wall Street analysts forecast SNY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SNY is 78.52 USD with a low forecast of 57.00 USD and a high forecast of 116.57 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
2 Buy
3 Hold
0 Sell
Moderate Buy
Current: 47.490
Low
57.00
Averages
78.52
High
116.57
Current: 47.490
Low
57.00
Averages
78.52
High
116.57
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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- Profit Growth Support: In Q4 2025, Sanofi reported a 12.7% year-over-year increase in operating profit to €2.34B, providing a solid foundation for the buyback program and indicating a strategic priority in capital allocation.
- Positive Market Reaction: Sanofi's stock price traded marginally higher during after-market hours on Monday, reflecting investor optimism regarding the buyback plan, which may further bolster market confidence in the company's future performance.
- Optimistic Outlook: Sanofi anticipates continued profitable growth over the next five years, aligning with its buyback strategy aimed at enhancing shareholder value through increased earnings per share.
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- Buyback Program Initiation: On January 29, 2026, Sanofi announced its intention to execute a share buyback program of up to €1 billion in 2026, aimed at enhancing shareholder value and boosting market confidence.
- Mandate Agreement Signed: On February 2, 2026, Sanofi entered into a mandate with an investment service provider for the buyback, ensuring shares will be repurchased between February 3 and December 31, 2026, reflecting the company's confidence in its stock value.
- Positive Market Reaction: This buyback program is expected to positively impact Sanofi's stock price, enhance earnings per share, and potentially attract more investor interest, further solidifying its position in the biopharmaceutical industry.
- Strategic Implications: By implementing this buyback plan, Sanofi not only demonstrates its strong cash flow and financial stability but also signals confidence in future growth, aiming to enhance shareholder returns and optimize its capital structure.
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Sanofi's Venglustat Achieves Success in Gaucher Disease Trial
- Gaucher Disease Trial Success: Sanofi's venglustat met its primary endpoint in the LEAP2MONO phase 3 trial for Gaucher disease, demonstrating statistically significant improvements in neurological symptoms at 52 weeks, indicating its potential in treating this condition.
- Multiple Secondary Endpoints Achieved: The drug also met three out of four secondary endpoints in the Gaucher study, further validating its effectiveness in improving patient quality of life, which may lay the groundwork for future market promotion.
- Fabry Disease Trial Missed Goals: Conversely, in the PERIDOT study for Fabry disease, venglustat did not significantly outperform the placebo group, despite both groups showing improvements in neuropathic and abdominal pain, highlighting efficacy differences across diseases.
- Global Application Plans: Sanofi intends to file applications for venglustat with global health regulators for Gaucher disease treatment, reflecting the company's optimistic outlook on the drug's market potential, which could drive future revenue growth.
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- Improper Promotion Allegations: Pfizer alleged that Sanofi breached several provisions, including promoting a prescription-only medicine to the public, making unsubstantiated superiority claims, and disparaging Pfizer's RSV vaccine and the UK's immunization program, highlighting unethical competitive practices.
- Regulatory Ruling Outcome: The Prescription Medicines Code of Practice Authority (PMCPA) ruled that Sanofi violated multiple clauses of the 2024 ABPI Code, particularly those related to high standards and misleading advertising, indicating significant compliance failures in pharmaceutical marketing.
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