SVRA FDA Decision CRL · 2025-05-27 Updated August 8, 2026 · next FDA decision on the calendar Refusal-to-File (CMC completeness), not a CRL
Price into the decision (T-120) PDUFA 5/27/25 $3.72 $2.32 12/10/24 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 date 2025-05-27
Outcome ✗ CRL ⚠ label corrected
Decision-day move -31.7%
T-120 run-up (low→high) +18.0% ($1.94→$3.4)
CRL reason Refusal-to-File (CMC completeness), not a CRL
Market-cap tier Nano
Cohort decision-day move (history) 8.0% median (n=116)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
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