Sanofi Faces FDA Delay and Trial Setback for Multiple Sclerosis Drug Tolebrutinib
Dec 15, 2025
Sanofi announced that the U.S. Food and Drug Administration (FDA) is delaying its review decision for tolebrutinib, an experimental drug aimed at treating non-relapsing secondary progressive multiple sclerosis (nrSPMS). The decision, originally expected by December 28, 2025, is now anticipated sometime after the first quarter of 2026.
This delay comes as Sanofi also reported that a late-stage clinical trial of tolebrutinib for a different form of multiple sclerosis did not meet its main objective. Following these updates, Sanofi's shares fell sharply.
Sanofi stated that it expects further guidance from the FDA by the end of the first quarter of 2026 regarding the regulatory review process for tolebrutinib.
What is tolebrutinib?
Tolebrutinib is an experimental drug developed by Sanofi to treat certain forms of multiple sclerosis, including non-relapsing secondary progressive multiple sclerosis.
Why has the FDA delayed its decision on tolebrutinib?
The FDA and Sanofi are continuing to discuss the regulatory application. As a result, the review process has been delayed, and a decision is now expected after the first quarter of 2026.
How did these events affect Sanofi's stock?
Sanofi's shares fell after the company announced the FDA delay and disappointing trial results for tolebrutinib.
What happened in the late-stage trial of tolebrutinib?
A late-stage clinical trial of tolebrutinib for a different form of multiple sclerosis did not achieve its main goal.
Sources
Press Release : Sanofi provides update on tolebrutinib regulatory submission in...
GlobeNewsWire
GlobeNewsWire
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis Ongoing discussions with the FDA regarding nrSPMS application have indicated regulatory decision for tolebrutinib is anticipated to be delayed Paris, December 15, 2025. Sanofi antic...
Sanofi Multiple Sclerosis Drug Hit by Double Setback
WSJ
WSJ
A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn't hit its main goal.
Sanofi flags delay in FDA's decision on tolebrutinib, shares fall
Reuters
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.
Sanofi stock slumps after two setbacks on multiple-sclerosis drug
Market Watch
Market Watch
Shares of Sanofi slumped on Monday as the French drugmaker said a U.S. regulatory review of its multiple-sclerosis drug won't be completed by the end of the year and that a trial for a different form of MS didn't succeed.
Sanofi shares slide as FDA delays MS drug decision and late-stage trial disappoi...
Invezz
Invezz
Shares of French pharmaceutical group Sanofi fell sharply on Monday after the company flagged another delay to a US regulatory decision for its experimental multiple sclerosis drug tolebrutinib and reported disappointing results from a late-stage clinical trial.
Sanofi: Today's Tolebrutinib Setback Shouldn't Worry Shareholders - This Is Why
Seeking Alpha
Seeking Alpha
Sanofi faces a setback as tolebrutinib fails its Phase 3 PPMS trial, halting regulatory pursuit for this indication. Meanwhile, an approval decision on the candidate has also been delayed. SNY's growth remains robust, with Q3 sales up 7% YoY, net income up 10%, and Dupixent driving ~35% of total rev...
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