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Principia Biopharma

Principia Biopharma

Biotechnology Company (Acquired)

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First BTK inhibitor advances toward approval for warm autoimmune hemolytic anemia

New Capabilities

Integrated into Sanofi

For 50,000 Americans with warm autoimmune hemolytic anemia, there's never been a disease-specific treatment. On February 9, 2026, the FDA granted breakthrough therapy designation to rilzabrutinib—the first BTK inhibitor to reach this milestone for the condition—signaling it may offer substantial improvement over existing therapies.

Updated May 27