Clinical Trials
Sanofi MS drug hits two setbacks
BioPharma Dive
Dec 15, 2025
Sanofi's Tolebrutinib, a drug acquired in a $3.7 billion buyout, failed a Phase 3 study in 'primary progressive' multiple sclerosis and faces a delayed U.S. approval decision for another form of the disease. The FDA decision on the medicine to treat an advanced form of multiple sclerosis will likely be delayed, with further guidance from the regulator at the end of the first quarter, the French drugmaker said, causing shares to plunge.
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