Quarterly ResultMay 12, 2026, 07:57 AM
Unicycive Therapeutics OLC PDUFA June 29; Q1 Net Loss $(12.8)M
AI Summary
Unicycive Therapeutics announced its financial results for the first quarter ended March 31, 2026, and provided a business update. The FDA review of its oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a PDUFA target action date of June 29, 2026. The company is also continuing commercial readiness activities for the potential launch of OLC. For Q1 2026, Unicycive reported a net comprehensive loss of $(12.8) million, or $(0.54) per share, primarily due to an increase in the fair value of its warrant liability. As of May 11, 2026, the company held $57.1 million in cash, cash equivalents, and marketable securities, sufficient to fund operations into 2027.
Key Highlights
- OLC NDA resubmission PDUFA target action date set for June 29, 2026.
- Q1 2026 Net comprehensive loss was $(12.8) million, compared to $0.5 million income in Q1 2025.
- Basic net loss per share for Q1 2026 was $(0.54).
- Cash, cash equivalents, and marketable securities totaled $57.1 million as of May 11, 2026.
- Research and Development expenses decreased to $1.6 million in Q1 2026 from $2.2 million in Q1 2025.
- General and Administrative expenses increased to $6.8 million in Q1 2026 from $5.8 million in Q1 2025.
- Change in fair value of warrant liability was a $(4.78) million expense in Q1 2026 versus $8.35 million income in Q1 2025.
Price Impact
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