Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.

EMA grants orphan designation to Sanofi’s rilzabrutinib, a reversible covalent BTK inhibitor, for IgG4-related disease: Paris Saturday, August 16, 2025, 09:00 Hrs [IST] Sanofi a ...

Paris: Sanofi has announced that the European Medicines Agency has granted orphan designation to rilzabrutinib, a reversible ...

Sanofi SNY announced that the European Medicines Agency (EMA) has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for treating IgG4-related disease (IgG4-RD). IgG4 ...

Sanofi's rilzabrutinib performed well in its phase 3 clinical trial, meaning the company can now apply for approval. The drug is a type of BTK inhibitor that combats disorders found in B ...

About Rilzabrutinib Rilzabrutinib is an oral Bruton’s tyrosine kinase inhibitor incorporating Sanofi’s TAILORED COVALENCY®3 technology being investigated for the treatment of immune-mediated ...

Sanofi SNY announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for sickle cell disease (SCD). The candidate exerts its effects through ...

In the LUNA 3 trial, treatment with rilzabrutinib (Sanofi) led to rapid and durable platelet responses, reduced bleeding and need for rescue therapy, and improved health-related quality of life in ...

Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended.

Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease Data from the positive Phase 2 study evaluating rilzabrutinib for the treatment of IgG4-related disease presented at ...

Data from the positive Phase 2 study evaluating rilzabrutinib for the treatment of IgG4-related disease presented at EULAR 2025Additional orphan designation underscores Sanofi commitment to advancing ...