Press Release: Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema
Sanofi - American Depositary Shares (SNY)
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sanofi.com/en/investors
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Source: GlobeNewswire
Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema Additional orphan designation reinforces Sanofi’s commitment to developing treatments for rare diseasesEfdoralprin 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 E
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- 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 emphysema [Yahoo! Finance]Yahoo! Finance
- 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
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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