Press Release: Sanofi's efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: Yahoo! Finance
Additional orphan designation reinforces Sanofi's commitment to developing treatments for rare diseases Efdoralprin alfa, an investigational restorative recombinant therapy, recently met all primary and key secondary endpoints in phase 2 head-to-head study versus a plasma-derived standard of care Paris, December 17, 2025 . The European Medicines Agency (EMA) has granted orphan designation to efdoralprin alfa (SAR447537, formerly known as INBRX-101), an investigational recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, for the potential treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema, a rare respiratory condition with great unmet medical need. The EMA grants orphan designation to potential new medicines addressing rare, life-threatening or debilitating medical diseases or conditions that affect no more than 5 in 10,000 individuals in the EU. Efdoralprin alfa demonstrated superiority to a standard of care plasma-derived therapy in adults with AA
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News
- Press release: Availability of the Q4 2025 Aide memoireGlobeNewswire
- Press Release: Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysemaGlobeNewswire
- Sanofi (SAN:CA) Discusses Year-End Late-Stage Pipeline Review With Focus on Clinical and Regulatory Developments Transcript [Seeking Alpha]Seeking Alpha
- Sanofi signs pair of billion-dollar biotech deals to bolster pipeline [Yahoo! Finance]Yahoo! Finance
- Bio-Techne Stock: Is TECH Underperforming the Healthcare Sector? [Yahoo! Finance]Yahoo! Finance
SNY
Sec Filings
- 12/15/25 - Form 6-K
- 12/12/25 - Form 6-K
- 12/3/25 - Form 6-K
- SNY's page on the SEC website