Already a Vigil Neuroscience investor, Sanofi has agreed to buy the rest of the biotech’s shares for $8 apiece, representing ...

Sanofi said the GEMINI 1 and 2 trials of tolebrutinib in relapsing forms of MS are fully enrolled and should read out in time to meet its plan of filing for regulatory approval in the US in 2024.

Sanofi has unveiled plans to invest “at least” $20bn into the US by 2030, with the commitment including a significant ...

Sanofi's oral BTK inhibitor tolebrutinib is heading towards an FDA decision in September as a potential treatment for multiple sclerosis (MS) after a priority review by the US regulator.

PRLs in Tolebrutinib Trials At ACTRIMS, Oh presented a post hoc analysis of PRLs in the phase III trials of the investigational Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib. "We're very ...

AB Science SA (Euronext - FR0010557264 - AB) today reports its revenues for the year 2024 and provides an update on its activities. CLINICAL DEVELOPMENT KEY EVENTS DURING THE YEAR 2024 AND SINCE ...

In December 2024, the drug tolebrutinib received the FDA’s “breakthrough therapy” designation for use in non-remitting SPMS. No DMTs have yet been approved to treat SPMS in a non-remitting ...

and Sanofi's experimental tolebrutinib. "The FDA appears to be focused on confirmed disability worsening endpoints where vidofludimus compares well in the PPMS population," the analysts wrote.

This was followed by regulatory acceptance of tolebrutinib, which is now set for a PDUFA date of September 28, complemented by 2 recent New England Journal paper publications. As François said ...