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 (5/2/25) through T+5. Run-up high $614.79 on 5/26/25, low $483.07 on 6/10/25 (T-120 to T-1). FDA decision 10/17/25. Historical price action, not a forecast.
Positioning before the decision
On Oct 3, 2025, 14 days before the decision date, at-the-money options priced a move of ±7.2% through Oct 24, 2025 (the first listed expiry after the decision; ATM implied volatility 37%). The stock closed +1.6% at the first close across the decision and +1.1% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
Decision facts
FDA decision date2025-10-17
DrugSolnerstotug (formerly SNS-101) with Libtayo - (VISTA)
IndicationOne microsatellite stable (MSS) endometrial cancer
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Solnerstotug (formerly SNS-101) with Libtayo approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for Solnerstotug (formerly SNS-101) with Libtayo in its current form, was announced on October 17, 2025. A CRL is not final; the primary source is linked on this page.
How did REGN stock react to the FDA decision?
On the decision day REGN moved +1.6%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.