Unicycive Therapeutics, Inc. is a U.S.-based biotechnology company dedicated to the creation of innovative treatments for kidney diseases. Its development pipeline includes Renazorb, a therapy for hyperphosphatemia in chronic kidney disease patients, and UNI 494, which is being developed to treat acute kidney injury. Founded in 2016, the firm is headquartered in Los Altos, California.
Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update
Unicycive Therapeutics reported Q2 financial results with a net loss of $1.7 million, or $0.06 per share, a significant improvement from the $6.5 million loss in the prior year, bolstered by $61.4 million in cash and marketable securities extending runway into 2027.
On the regulatory front, the company confirmed the FDA has assigned a facility inspection for the third-party manufacturer of OLC, marking a necessary step to resubmit the NDA following a Complete Response Letter that cited recurring manufacturing deficiencies but no clinical concerns.
Management continues to advance commercial readiness for OLC, including the UniSource reimbursement hub, and plans to engage the medical community at upcoming kidney disease conferences in September.