Unicycive Therapeutics, Inc.
Unicycive Therapeutics, Inc. (Nasdaq Capital Market: UNCY) is a clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet medical needs in kidney disease. Founded in 2016, the company operates with a streamlined drug development… From the company’s description.
Margins and return on equity change in ; everything else in percent. Fewer shares and less debt are shown plainly, not as bad news — it depends what you make of buybacks. Dotted labels explain each measure. is shown separately from the annual figures.
What Unicycive Therapeutics, Inc. does
In the company’s own words
Unicycive Therapeutics, Inc. (Nasdaq Capital Market: UNCY) is a clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet medical needs in kidney disease. Founded in 2016, the company operates with a streamlined drug development platform designed to accelerate the advancement of promising therapies from discovery through commercialization.
The company's pipeline comprises two primary product candidates. Oxylanthanum carbonate is a next-generation phosphate binder in development for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The company submitted a New Drug Application to the FDA in September 2024 and received a Complete Response Letter in June 2025 related to manufacturing compliance issues. Following a Type A meeting with the FDA in October 2025 and resubmission in December 2025, the FDA accepted the resubmission in January 2026 with a target action date of June 29, 2026. UNI-494 is a novel drug candidate in development for treating acute kidney injury, with a Phase I clinical study completed in healthy volunteers in 2024.
Unicycive's business model centers on in-licensing technologies and drug candidates, then pursuing development, regulatory approval, and commercialization. Both current product candidates were initially developed externally—oxylanthanum carbonate was licensed from Spectrum Pharmaceuticals, and UNI-494 was licensed from Sphaera Pharma. The company has established strategic partnerships for global commercialization, including licensing agreements with Lee's Pharmaceutical Holdings Limited for Greater China and Lotus Pharmaceutical Co., Ltd. for select Asian markets.
The company does not operate manufacturing facilities and relies on contract manufacturing organizations for clinical and commercial production. Shilpa Medicare Ltd. serves as the primary contract development and manufacturing organization for oxylanthanum carbonate. Unicycive is transitioning from a clinical-stage organization to a commercial-stage company in anticipation of potential FDA approval and U.S. launch of oxylanthanum carbonate, having assembled a commercial leadership team with extensive nephrology and dialysis market experience. The company's website is located at www.unicycive.com.
Company details
- Sector
- Health Care
- Industry (SIC)
- Pharmaceutical Preparations
- Headquarters
- MOUNTAIN VIEW, CA
- Fiscal year end
- December
- CIK
- 1766140
- SIC
- 2834
Financial performance, year by year
Fiscal 2021–2025 · USDThe full income statement, balance sheet and cash flow for each of these years — every figure traceable to its filing — is on the Financials tab with a free account.
Who owns Unicycive Therapeutics, Inc. — and what changed
Funds as of 2026Q2 · superinvestors as of 2026-06-30
Largest fund holders · Unicycive Therapeutics, Inc.’s weight in each
Fund ownership is a floor, not a census — pensions, insurers and people holding shares directly are not visible here.
Fund ownership counts N-PORT filers only, so it is a floor rather than a census — pensions, insurers and direct holders are not visible here, and the remainder is not “held by individuals”.
Could not be determined for this company: bond issues.
Every fund and institutional holder, quarter by quarter, is on the Ownership tab with a free account.
Recent filings
All filings →Each filing opens into its own statements and disclosures here.
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