Unicycive Therapeutics, Inc. (UNCY)

In the past six months, Unicycive Therapeutics announced its full-year 2025 financial results and provided a business update, reporting that the FDA accepted its New Drug Application (NDA) resubmission for oxylanthanum carbonate (OLC), with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026, and commercial readiness for a potential Q3 2026 launch is underway. The net loss for the year ended December 31, 2025, decreased compared to 2024. Unicycive Therapeutics announced it would present at the 25th Annual Needham Virtual Healthcare Conference and participated in a fireside chat at Guggenheim's Emerging Outlook: Biotech Summit. Between April 10, 2025, and April 9, 2026, the company's share price increased and the company's stock has a 52-week range between $3.71 and $11.00.

There is no specific information available regarding demand seasonality for Unicycive Therapeutics, Inc.'s products and services. As a clinical-stage biotechnology company developing investigational treatments for kidney diseases, traditional demand seasonality is not typically applicable to its current business model.

Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on identifying, developing, and commercializing novel therapies to address unmet medical needs, primarily in kidney diseases, within the United States. The company's lead product candidate, Oxylanthanum Carbonate, is under FDA review for hyperphosphatemia in chronic kidney disease patients on dialysis. Another product candidate, UNI-494, is intended for the treatment of conditions related to acute kidney injury and has been granted Orphan Drug Designation by the FDA for the prevention of Delayed Graft Function in kidney transplant patients. The company also evaluates the licensing of technologies and drugs for orphan diseases, other renal, liver, and metabolic diseases affecting fibrosis and inflammation.

Unicycive Therapeutics, Inc. primarily focuses its operations and commercialization efforts in the United States and is based in Los Altos, California.

Unicycive Therapeutics' reputation was significantly impacted by a federal securities fraud class action lawsuit filed covering the period from March 29, 2024, through June 27, 2025. The lawsuit alleged that the company overstated its readiness to meet FDA manufacturing compliance requirements and exaggerated the regulatory prospects of its New Drug Application (NDA) for oxylanthanum carbonate (OLC).

As of April 8, 2026, Unicycive Therapeutics, Inc. has 40 institutional owners and shareholders holding a total of 8,168,570 shares, representing approximately 40.42% of the company's stock. Major institutional owners include Vivo Capital, LLC, Millennium Management Llc, Octagon Capital Advisors LP, Nantahala Capital Management, LLC, Great Point Partners Llc, Vanguard Group Inc, Logos Global Management LP, Citadel Advisors Llc, Cantor Fitzgerald, L. P., and Geode Capital Management, Llc. Other notable institutional investors include OMERS ADMINISTRATION Corp, State Street Corp, BlackRock, Inc., and RA CAPITAL MANAGEMENT, L.P.