PHIO FDA Decision CRL · 2025-01-13 Updated August 8, 2026 · next FDA decision on the calendar Mislabel: PH-762 Phase 1b data, clinical-stage
Price into the decision (T-120) PDUFA 1/13/25 $4.457 $1.69 7/29/24 Daily close, T-120 (7/29/24) through T+5. Run-up high $4.457 on 7/29/24, low $1.69 on 1/9/25 (T-120 to T-1). FDA decision 1/13/25. Historical price action, not a forecast.
Decision facts FDA decision date 2025-01-13
Outcome ✗ CRL ⚠ label corrected
Decision-day move +290.5%
T-120 run-up (low→high) +137.0% ($1.69→$6.6)
CRL reason Mislabel: PH-762 Phase 1b data, clinical-stage
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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