• Unicycive Therapeutics highlighted lead phosphate binder candidate oxylanthanum carbonate (OLC) with FDA review of its resubmitted NDA underway under 505(b)(2), carrying a June 29, 2026 PDUFA date.
• Resubmission followed a late 2025 Type A meeting focused on resolving a single CRL deficiency tied to compliance status at a third-party manufacturing vendor.
• Company framed OLC as a potential lower-pill-burden alternative to lanthanum carbonate therapy, with tablets designed to be swallowed whole rather than chewed.
• In OLC pivotal safety population (N=86), treatment-related adverse events at or above 5% were diarrhea 9% and vomiting 6%; discontinuations due to adverse events were 6%.
• Presentation cited cash runway into 2027 to support regulatory work, potential approval, and launch planning; it also highlighted UNI-494 in development for acute kidney injury.

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