Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Refusal-to-File (CMC completeness), not a CRL
Price into the decision (T-120)
Daily close, T-120 (12/10/24) through T+5. Run-up high $3.72 on 12/17/24, low $2.32 on 3/5/25 (T-120 to T-1). FDA decision 5/27/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-05-27
Outcome✗ CRL⚠ label corrected
Decision-day move-31.7%
T-120 run-up (low→high)+18.0% ($1.94→$3.4)
CRL reasonRefusal-to-File (CMC completeness), not a CRL
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was source-verified approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on May 27, 2025. A CRL is not final; the primary source is linked on this page.
How did SVRA stock react to the FDA decision?
On the decision day SVRA moved -31.7%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.