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PHIO FDA Decision CRL · 2025-01-13

Updated September 14, 2026·next FDA decision on the calendar

Mislabel: PH-762 Phase 1b data, clinical-stage

Price into the decision (T-120)

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 date2025-01-13

Outcome✗ CRL⚠ label corrected

Decision-day move+290.5%

T-120 run-up (low→high)+137.0% ($1.69→$6.6)

CRL reasonMislabel: PH-762 Phase 1b data, clinical-stage

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 January 13, 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 PHIO stock react to the FDA decision?

On the decision day PHIO moved +290.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.