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UNCY FDA decision — Jun 29, 2026

✕ COMPLETE RESPONSE LETTER

CRL for oxylanthanum carbonate (Jun 30 2026) — third-party manufacturing (same as 2025); no efficacy/safety issues

Run-up into the decision (T-120 → T+5)

PDUFA 6/29/26$8.56$5.521/12/26
Daily close, T-120 (1/12/26) through T+5. Run-up high $8.56 on 5/18/26, low $5.52 on 1/12/26 (T-120 to T-1). FDA decision 6/29/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-29
OutcomeCRL
Drug / candidateOxylanthanum Carbonate (OLC)
IndicationKidney disease
CompanyUnicycive Therapeutics
Market-cap tierMicro
120-day run-up (T-120→T-1)+29.2%
Cohort decision-day move (history)±7% median

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.