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SNY FDA Decision CRL · 2025-12-28

Updated September 23, 2026·next FDA decision on the calendar

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.

Decision facts

FDA decision date2025-12-28

DrugTolebrutinib

IndicationMultiple sclerosis (nrSPMS)

Outcome✗ CRLprimary-sourced

Decision-day move-0.2%

T-120 run-up (low→high)+4.0% ($45.07→$52.34)

ValidationVerified 2026-08-12: SEC filing 0001193125-25-332163 of 2025-12-29 containing 'complete response letter'

Market-cap tierLarge

Cohort decision-day move (history)1.0% median (n=835)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was Tolebrutinib approved by the FDA?

Not in this review cycle. On December 28, 2025 the FDA issued a Complete Response Letter, declining to approve the application for Tolebrutinib in its current form. 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.