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28, 2025 FDA designations: Breakthrough Therapy, Priority Review Financial forecast (reported in millions) tolebrutinib oral Manufacturer: Sanofi Proposed indications Clinical overview Mechanism of action Tolebrutinib is a Brutons tyrosine kinase (BTK) inhibitor that crosses the blood-brain barrier and regulates B-lymphocytes and disease-associated microglia within the CNS, thereby targeting smoldering neuroinflammation associated with MS progression

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