Sanofi (SNY) said Monday its phase 3 trial of its experimental drug, tolebrutinib, did not meet the main goal of delaying disability progression in patients with primary progressive multiple sclerosis, a form that accounts for about 10% of multiple sclerosis cases.
The company said it will not seek regulatory approval for this indication.
The drugmaker said that the drug's safety profile was in line with earlier studies, though drug-induced liver injury remains a known risk and requires strict liver monitoring.
Tolebrutinib remains provisionally approved in the United Arab Emirates for non-relapsing secondary progressive multiple sclerosis and is under regulatory review in the EU and other jurisdictions, the company said.
Sanofi will conduct an impairment test on the drug's intangible asset value, with results to be disclosed alongside its Q4 and full-year 2025 results in January 2026, the company said, adding that it will not affect its 2025 financial guidance or business earnings.
Shares of the company were down 2.6% in Monday's premarket activity.
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