The USA's Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative ...

Experts see tolebrutinib as part of a broader shift toward treatments that target the neurodegeneration in MS, not just its ...

(RTTNews) - French drug major Sanofi (SNY) announced Friday that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with ...

Sanofi reports positive phase 3 HERCULES study data for tolebrutinib in non-relapsing secondary progressive multiple sclerosis, showing a 31% delay in disability progression. Study also revealed ...

In 2022, the FDA placed a partial clinical hold on Sanofi’s phase III studies on tolebrutinib in MS and myasthenia gravis (MG) indications after the regulatory agency identified cases of drug ...

Tolebrutinib, from the $3.7 billion takeover of Principia in 2020, belongs to a class of compounds known as Bruton's tyrosine kinase (BTK) inhibitors, which has also attracted Novartis and Roche.

In a mitigation of the setback, Sanofi said a separate third late-stage trial showed that tolebrutinib met the main goal to treat a progressive - or steadily worsening - form of MS, which is less ...

Sanofi SA’s brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib, met the primary endpoint in the phase III Hercules trial in non-relapsing secondary progressive multiple sclerosis ...

The completion of this study could positively influence Sanofi’s stock performance and investor sentiment, as successful results may position Tolebrutinib as a leading treatment for NRSPMS.