Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
Daily close, T-120 (7/11/25) through T+5. Run-up high $52.34 on 11/17/25, low $45.07 on 9/29/25 (T-120 to T-1). FDA decision 12/28/25. Historical price action, not a forecast.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Tolebrutinib approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for Tolebrutinib in its current form, was announced on December 28, 2025. A CRL is not final; the primary source is linked on this page.
What was Tolebrutinib under FDA review for?
The application covered Multiple sclerosis (nrSPMS). The FDA declined to approve the application in its current form on December 28, 2025.
How did SNY stock react to the FDA decision?
On the decision day SNY moved -0.2%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.