Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the ...

French drugmaker Sanofi on Monday flagged another delay to a U.S. regulatory decision for its experimental multiple sclerosis ...

A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of ...

Sanofi will not be pursuing approval of tolebrutinib for PPMS, and an FDA decision on the therapy in nonrelapsing SPMS will ...

Tolebrutinib, which Sanofi acquired in a $3.7 billion buyout, failed a Phase 3 study in “primary progressive” multiple ...

So continues the rocky path for the drug, which Sanofi picked up in its $3.7 billion buyout of Principia Biopharma back in ...

Sanofi provides update on tolebrutinib in primary progressive multiple sclerosisPERSEUS phase 3 study in primary progressive multiple sclerosis ...

Sanofi drug faces FDA delay following a failed late-stage trial for multiple sclerosis, with regulatory guidance expected by Q1 2024.

Tolebrutinib was one of three oral BTK inhibitors that Sanofi acquired as part of its $3.7 billion buyout of Principia ...

Tolebrutinib is currently being reviewed by the Food and Drug Administration (FDA) for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS). A regulatory decision on the ...

Sanofi shares slide after FDA delays review of its MS drug tolebrutinib and a late-stage trial fails to meet its main goal.

The PERSEUS trial was a global, double-blind, randomized Phase 3 study comparing tolebrutinib to placebo in PPMS patients.