Press Release: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
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Sanofi has received priority review from the FDA for tolebrutinib, a potential breakthrough therapy for non-relapsing secondary progressive multiple sclerosis (nrSPMS). The drug is unique in its ability to cross the blood-brain barrier and target smoldering neuroinflammation, which could potentially slow disability progression. The target FDA decision date is September 28, 2025.
March 25, 2025 | 6:15 am
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Tolebrutinib's priority review represents a significant potential milestone for Sanofi's neurology pipeline, targeting an unmet medical need in multiple sclerosis treatment.
Priority FDA review suggests strong clinical data and potential market opportunity for Sanofi's novel MS treatment, which could positively impact stock performance
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100