Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Daily close, T-120 (9/9/25) through T+5. Run-up high $52.34 on 11/20/25, low $45.07 on 10/2/25 (T-120 to T-1). FDA decision 2/24/26. 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 primary-sourced approved by the FDA?
Yes. The approval of the application for primary-sourced was announced on February 24, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
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.