Quarterly ResultMay 12, 2026, 07:07 AM
Unicycive OLC FDA Review on Track for June 29 PDUFA; Q1 Net Loss $(12.8)M
AI Summary
Unicycive Therapeutics announced that the FDA review of its oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. The company is continuing commercial readiness activities for a potential launch. For the first quarter ended March 31, 2026, Unicycive reported a net comprehensive loss of $(12.8) million, or $(0.54) per share, compared to a net income of $0.5 million, or $0.04 per share, in the prior year period. As of May 11, 2026, cash, cash equivalents, and marketable securities totaled $57.1 million, expected to fund operations into 2027.
Key Highlights
- FDA PDUFA target action date for OLC NDA resubmission is June 29, 2026.
- Q1 2026 net comprehensive loss was $(12.8) million, or $(0.54) per share.
- Q1 2025 net comprehensive income was $0.5 million, or $0.04 per share.
- Cash, cash equivalents, and marketable securities totaled $57.1 million as of May 11, 2026.
- Research and Development expense decreased to $1.6 million in Q1 2026 from $2.2 million in Q1 2025.
- General and Administrative expense increased to $6.8 million in Q1 2026 from $5.8 million in Q1 2025.
- Change in fair value of warrant liability was $(4.78) million in Q1 2026 vs $8.348 million income in Q1 2025.