Here are the 10-K annual reports from Unicycive Therapeutics, Inc. (UNCY) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-K covers the audited annual report, with the full financial statements, so if you follow UNCY and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full UNCY filings page.
Unicycive Therapeutics’ annual report outlines its kidney-focused drug pipeline, regulatory progress, and commercial plans. The company’s lead candidate, oxylanthanum carbonate (OLC), targets hyperphosphatemia in dialysis patients and is being reviewed via the 505(b)(2) pathway. After a Complete Response Letter tied to a third-party manufacturer, Unicycive resubmitted its OLC NDA in December 2025; the FDA accepted it as a Class II resubmission with a new PDUFA target action date of June 29, 2026. The report describes positive Phase 2 tolerability data and bioequivalence to Fosrenol, along with a concentrated U.S. launch strategy focused on large dialysis organizations and high-prescribing nephrologists. A second program, UNI-494 for acute kidney injury and delayed graft function, has orphan drug designation but further development has been deprioritized while the company focuses on OLC commercialization.