Unicycive Therapeutics, Inc. (UNCY)

Unicycive Therapeutics, Inc. regained Nasdaq compliance in July 2025 following a reverse stock split. The company announced its intention to resubmit the New Drug Application (NDA) for OLC by year-end 2025, following positive discussions with the FDA. Unicycive presented new data for OLC at the American Society of Nephrology (ASN) Kidney Week 2025, highlighting its ability to significantly reduce pill burden for patients. The company announced its Q3 2025 financial results, reporting a net loss of $6.0 million and a cash balance of $42.7 million. In November 2025, the company saw price target decreases by analysts and participated in investor events in December 2025. Between January 13, 2025, and January 12, 2026, the share price declined.

As a clinical-stage biotechnology company focused on developing therapies for kidney diseases, Unicycive Therapeutics, Inc. does not currently generate revenue from product sales, so traditional demand seasonality is not a significant factor. The "demand" for its drug candidates is primarily driven by the medical need for effective treatments for kidney diseases and the potential for regulatory approval and subsequent adoption by the medical community.

Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on identifying, developing, and commercializing novel therapies for patients with kidney diseases in the United States. The company's major product candidates include Renazorb (OLC), a phosphate-binding agent under FDA review for hyperphosphatemia in chronic kidney disease patients on dialysis, and UNI-494, an investigational treatment for acute kidney injury with orphan drug designation for preventing Delayed Graft Function in kidney transplant patients, which has completed a Phase 1 safety study.

Unicycive Therapeutics, Inc. is based in Los Altos, California, and focuses on addressing unmet medical needs in the United States. Its investigational treatment UNI-494 has completed Phase 1 safety testing in the United Kingdom.

Unicycive Therapeutics generally holds a "Moderate Buy" consensus rating from analysts. Regaining Nasdaq compliance, resubmitting the NDA for OLC, and presenting positive clinical data for OLC have positively affected the company's reputation. As a clinical-stage biotechnology company, its reputation is heavily tied to the progress and success of its drug development pipeline and regulatory approvals.

Unicycive Therapeutics, Inc.'s ownership structure includes institutional, insider, and retail investors. Institutional investors own approximately 29.25% to 29.33% of the company's stock, insiders own 21.10% to 21.29%, and retail investors and public companies own 49.46% to 49.57%. Major institutional owners include Vivo Capital, LLC, and Octagon Capital Advisors LP. Key individual owners include Shalabh K. Gupta, Gaurav Aggarwal, and Douglas Jermasek.