Sanofi (SNY,SAN.PA) said it anticipates that the review process for the US regulatory review of tolebrutinib in non-relapsing secondary progressive multiple sclerosis will extend beyond the US target action date of December 28, 2025. The company expects further guidance from the FDA by the end of the first quarter of 2026. In response to an FDA request, Sanofi has submitted an expanded access protocol for tolebrutinib in nrSPMS.
Tolebrutinib is an investigational, oral, brain-penetrant Bruton's tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in multiple sclerosis.
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Business News
April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.