Quarterly ResultAug 12, 2026, 07:21 AM
Unicycive: FDA Inspection Assigned for OLC; Cash $61.4M
AI Summary
Unicycive Therapeutics announced its Q2 2026 financial results and a business update, highlighting that the FDA has assigned a facility inspection for its third-party manufacturing vendor of oxylanthanum carbonate (OLC). The company plans to resubmit its New Drug Application (NDA) for OLC following a successful inspection. Financially, Unicycive reported $61.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026, providing a runway into 2027. The net loss for the quarter significantly decreased to $(1.7) million.
Key Highlights
- FDA assigned facility inspection for third-party OLC manufacturing vendor.
- Company expects to resubmit NDA for oxylanthanum carbonate (OLC) after successful inspection.
- Unaudited cash, cash equivalents, and marketable securities totaled $61.4 million as of June 30, 2026.
- Expected cash runway extends into 2027.
- R&D expense increased to $2.8 million for Q2 2026 from $1.8 million in Q2 2025.
- G&A expense rose to $7.4 million for Q2 2026 from $5.2 million in Q2 2025.
- Net loss decreased to $(1.7) million, or $(0.06) per share, for Q2 2026 from $(6.5) million in Q2 2025.
Price Impact
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