Press Release: Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
Company Research
Source: GlobeNewswire
Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia Rilzabrutinib is the first and only investigational BTKi for warm autoimmune hemolytic anemia to be designated Breakthrough Therapy by the FDA Rilzabrutinib helps address complex immune-system dysregulation through multi-immune modulationRilzabrutinib holds global regulatory designations across multiple rare diseases, underscoring its broad therapeutic potential Paris, February 9, 2026. The US Food and Drug Administration (FDA) has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disorder marked by the destruction of red blood cells. The Japanese Ministry of Health, Labour and Welfare has also provided rilzabrutinib an orphan designation for the same condit
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- Press Release: Sanofi's rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia [Yahoo! Finance]Yahoo! Finance
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SNY
Sec Filings
- 2/6/26 - Form 6-K
- 2/5/26 - Form S-8
- 1/29/26 - Form 6-K
- SNY's page on the SEC website