Oxylanthanum Carbonate (OLC)

May 12, 2026 — Unicycive Therapeutics, Inc. (Nasdaq: UNCY) reported first-quarter 2026 financial results (quarter ended March 31, 2026) and provided a business update focused on oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The U.S. FDA review of Unicycive’s OLC New Drug Application (NDA) resubmission is “on track,” with a PDUFA target action date of June 29, 2026; the company notes the FDA raised no concerns on preclinical, clinical, or safety data in the original NDA, and the resubmission addressed third-party manufacturing vendor drug product progress. Unicycive said it continues commercial readiness planning and intends to support access/reimbursement via its UniSource™ hub.

Financially, unaudited cash, cash equivalents, and marketable securities were $57.1M as of May 11, 2026, expected to fund operations into 2027. Q1 2026 R&D expense was $1.6M (vs $2.2M Q1 2025), G&A was $6.8M (vs $5.8M), and net comprehensive loss attributable to common stockholders (basic) was $12.8M or $(0.54)/share (vs $0.5M or $0.04/share), driven mainly by warrant liability fair value changes.