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Sanofi Wins EMA Orphan Designation for Efdoralprin Alfa in Rare Emphysema

Story Highlights
  • The EMA granted orphan designation to Sanofi’s efdoralprin alfa for AATD emphysema.
  • Efdoralprin alfa outperformed plasma-derived standard care in Phase 2, bolstering Sanofi’s rare-disease push.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Sanofi Wins EMA Orphan Designation for Efdoralprin Alfa in Rare Emphysema

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Sanofi ( (SNY) ) has provided an announcement.

On December 17, 2025, Sanofi announced that the European Medicines Agency granted orphan designation to efdoralprin alfa (SAR447537), its investigational recombinant human alpha-1 antitrypsin-Fc fusion protein, for the potential treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema, a rare and debilitating respiratory disease. The candidate recently showed superiority to a plasma-derived standard-of-care therapy in a global Phase 2 head-to-head trial, meeting all primary and key secondary endpoints with dosing every three or four weeks, adding to prior U.S. fast track and orphan drug designations and reinforcing Sanofi’s strategy of building a differentiated rare-disease portfolio in an indication where no new therapies have been introduced since 1987 and where underdiagnosis remains high.

The most recent analyst rating on (SNY) stock is a Hold with a $57.00 price target. To see the full list of analyst forecasts on Sanofi stock, see the SNY Stock Forecast page.

Spark’s Take on SNY Stock

According to Spark, TipRanks’ AI Analyst, SNY is a Outperform.

Sanofi’s overall stock score reflects its strong earnings performance and attractive valuation, which are the most significant factors. The company’s financial stability and positive earnings call guidance further support the score, despite some technical analysis indicators suggesting a neutral trend.

To see Spark’s full report on SNY stock, click here.

More about Sanofi

Sanofi is an R&D-driven, AI-powered biopharmaceutical company that develops medicines and vaccines with a strong focus on immunology and rare diseases, aiming to address urgent healthcare challenges worldwide. Listed on Euronext Paris and Nasdaq, the group leverages its innovative pipeline to drive growth while targeting conditions with significant unmet medical need.

Average Trading Volume: 2,993,219

Technical Sentiment Signal: Hold

Current Market Cap: $117.5B

For a thorough assessment of SNY stock, go to TipRanks’ Stock Analysis page.

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