Sanofi Granted Orphan Designation by EMA for Efdoralprin Alfa
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 17 2025
0mins
Should l Buy SNY?
Source: NASDAQ.COM
Orphan Designation Granted: The European Medicines Agency has granted orphan designation to efdoralprin alfa, an investigational treatment for alpha-1 antitrypsin deficiency-related emphysema.
Significant Medical Need: This designation emphasizes the unmet medical need for patients suffering from AATD-related emphysema and the potential of efdoralprin alfa to offer new therapeutic options.
Regulatory Status: Efdoralprin alfa has also received fast track and orphan drug designations from the US FDA, but its safety and efficacy are still under evaluation.
Future Plans: Sanofi intends to present clinical data at an upcoming medical meeting and will engage with global regulatory authorities regarding the next steps for the drug's development.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy SNY?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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: 47.830
Low
57.00
Averages
78.52
High
116.57
Current: 47.830
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.
Sanofi's Rilzabrutinib Receives Breakthrough Therapy Designation
- 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.
See More
Biogen Shares Increase Despite Falling Multiple Sclerosis Revenue and Ongoing Declines
- Stock Performance: Biogen's stock experienced an increase on Friday despite facing declining sales.
- Drug Portfolio Issues: The company's drug portfolio showed poor performance in the fourth quarter, contributing to investor concerns.
See More
Cardinal Health Shares Surge Following Earnings Report as CEO Discusses Success Factors.
- Fiscal-Year Outlook Increase: Cardinal Health has raised its fiscal-year outlook for the second time in less than a month.
- Positive Financial Performance: The company’s recent adjustments indicate strong financial performance and confidence in future growth.
See More
Sanofi Announces €1B Share Buyback Program
- Buyback Program Initiated: Sanofi has signed a mandate with an investment service provider for a €1B share buyback program, set to run from February 3, 2026, to December 31, 2026, demonstrating the company's confidence in its stock value.
- 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.
See More
Sanofi Announces €1 Billion Share Buyback Program
- 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.
See More
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.
See More
Sanofi's Rilzabrutinib Receives Breakthrough Therapy Designation
- 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.
See More
Biogen Shares Increase Despite Falling Multiple Sclerosis Revenue and Ongoing Declines
- Stock Performance: Biogen's stock experienced an increase on Friday despite facing declining sales.
- Drug Portfolio Issues: The company's drug portfolio showed poor performance in the fourth quarter, contributing to investor concerns.
See More
Cardinal Health Shares Surge Following Earnings Report as CEO Discusses Success Factors.
- Fiscal-Year Outlook Increase: Cardinal Health has raised its fiscal-year outlook for the second time in less than a month.
- Positive Financial Performance: The company’s recent adjustments indicate strong financial performance and confidence in future growth.
See More
Sanofi Announces €1B Share Buyback Program
- Buyback Program Initiated: Sanofi has signed a mandate with an investment service provider for a €1B share buyback program, set to run from February 3, 2026, to December 31, 2026, demonstrating the company's confidence in its stock value.
- 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.
See More
Sanofi Announces €1 Billion Share Buyback Program
- 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.
See More
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.
See More
