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Sanofi flags delay in FDA’s decision on tolebrutinib, shares fall

By Thomson Reuters Dec 15, 2025 | 2:49 AM

Dec 15 (Reuters) – French pharmaceutical group Sanofi said on Monday ‍the U.S. Food and Drug Administration’s decision on its investigative drug to treat ‌multiple sclerosis was ‌expected to be delayed until the first quarter of 2026, from the previously ​communicated December 28.

Discussions with the ‍FDA regarding ​the use of ​tolebrutinib in treatment of ‍non-relapsing secondary progressive multiple sclerosis have indicated that the decision will likely be ‍delayed, Sanofi said.

Shares in the drugmaker were down 5% ‍at ‍0830 GMT, ​at the bottom ​of ⁠the SBF 120 ‌index of Paris’ most traded stocks.

(Reporting by Mathias de Rozario in Gdansk, editing by Milla ⁠Nissi-Prussak)