pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › FDA Decisions › SVRA 2025-05-27

SVRA FDA Decision CRL · 2025-05-27

Updated ·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$2.3212/10/24
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 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
Primary sourceView filing ↗
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=117)

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 source-verified approved by the FDA?

Not in this review cycle. On May 27, 2025 the FDA issued a Complete Response Letter, declining to approve the application for source-verified in its current form. 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.