Sanofi SNY reported second-quarter 2025 adjusted earnings of 90 cents per American depositary share, which missed the Zacks ...

(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 ...

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.

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

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 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 ...

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.

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 ...

Sanofi’s recent clinical study, titled ‘A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of ...

The not-so-good news came from the remaining two trials that put tolebrutinib through its paces for relapsing MS. Sanofi said the drug didn't demonstrate significance in its primary endpoint of ...

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 ...