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UNCY PDUFA Date: Oxylanthanum Carbonate (OLC)

FDA decision (PDUFA) target 2026-06-29 · Unicycive Therapeutics Inc. · Kidney disease
More Obesity & Metabolic FDA decisions →All June 2026 PDUFA dates →

The story PRIOR CRL

Oxylanthanum Carbonate (OLC) is under FDA review to treat high blood phosphate (hyperphosphatemia) in patients on kidney dialysis - a daily pill burden for dialysis patients. Regulatory history: the FDA issued a Complete Response Letter in June 2025 - this PDUFA is the resubmission. The prior CRL cited only chemistry/manufacturing (CMC) issues - a factory fix, not an efficacy or safety problem - so no new trial was required. Balance sheet: about 23 months of cash, runway into 2027 (company-guided).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthACHV . 2026-06-20Same area: Nephrology . CytisiniclineVERA . 2026-07-07Same area: Nephrology . AtaciceptGSK-tebipenem-hbr . 2026-06-18Same month decision . Tebipenem HBr (SPR994)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

UNCY run-up into the PDUFA (last ~120 days)

$8.56$6.11
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-06-29
Drug / candidateOxylanthanum Carbonate (OLC)
IndicationKidney disease
CompanyUnicycive Therapeutics Inc.
Market-cap tierMicro
Cohort decision-day move (history)±7% median
ClinicalTrials.govNCT06218290 · completed

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FAQ

When is the UNCY PDUFA date?
The FDA PDUFA target date for UNCY (Unicycive Therapeutics Inc.) is 2026-06-29 for Oxylanthanum Carbonate (OLC). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is UNCY's drug Oxylanthanum Carbonate (OLC)?
Oxylanthanum Carbonate (OLC) is Unicycive Therapeutics Inc.'s candidate under FDA review for Kidney disease.
What typically happens to a micro-cap stock into a PDUFA date?
Historically, micro-cap names had a median decision-day move around ±7% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.