Unicycive Therapeutics Stock Price, News & Analysis

Unicycive Therapeutics, Inc. (UNCY) is a clinical-stage biotechnology company that focuses on developing novel treatments for kidney diseases. According to company disclosures and recent press releases, Unicycive is advancing investigational therapies for patients with chronic kidney disease (CKD) on dialysis and for conditions related to acute kidney injury. The company’s common stock trades on the Nasdaq Capital Market under the symbol UNCY.

Business Focus and Therapeutic Area

Unicycive describes itself as a biotechnology company developing therapies for patients with kidney disease. Its work centers on serious renal conditions, including hyperphosphatemia in CKD patients on dialysis and complications associated with acute kidney injury and kidney transplantation. The company’s programs are positioned in the nephrology space, with an emphasis on improving phosphate control and addressing mitochondrial dysfunction in kidney disease.

Lead Investigational Therapy: Oxylanthanum Carbonate (OLC)

Unicycive’s lead investigational treatment is oxylanthanum carbonate (OLC), an oral phosphate binder being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Company materials describe OLC as a novel phosphate binding agent that leverages proprietary nanoparticle technology to deliver high phosphate binding potency. This design is intended to reduce the number and size of pills that patients must take to manage hyperphosphatemia.

OLC is being pursued through the U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway. The New Drug Application (NDA) submission package for OLC is based on three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in CKD patients on dialysis), multiple preclinical studies, and chemistry, manufacturing and controls (CMC) data. Unicycive has reported that OLC is protected by a global patent portfolio, including issued composition-of-matter patents with stated exclusivity until 2031 and potential patent term extension until 2035.

Clinical data highlighted by the company indicate that in an open-label pivotal trial in CKD patients on dialysis with hyperphosphatemia, OLC was well tolerated and enabled serum phosphate control in more than 90% of patients, with a relatively low pill burden. Company communications emphasize that OLC significantly reduced pill burden in terms of both pill volume and pill count compared to pre-trial phosphate binder therapy, and that systemic absorption of OLC (measured as lanthanum) was minimal to none in CKD patients.

Target Condition: Hyperphosphatemia in CKD on Dialysis

Unicycive describes hyperphosphatemia as a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). The company cites external research indicating that hundreds of thousands of individuals in the United States require medication annually to control phosphate levels. Uncontrolled hyperphosphatemia is characterized as strongly associated with increased death and hospitalization for CKD patients on dialysis.

Standard management of hyperphosphatemia, as summarized in Unicycive’s materials, involves restricting dietary phosphorus intake and using oral phosphate binding drugs with meals to facilitate fecal elimination of dietary phosphate rather than absorption into the bloodstream. OLC is being developed within this treatment paradigm, with a focus on phosphate control and pill burden.

Second Investigational Program: UNI-494

Unicycive’s second investigational treatment is UNI-494, which the company describes as intended for the treatment of conditions related to acute kidney injury. UNI-494 has been granted orphan drug designation (ODD) by the FDA for the prevention of delayed graft function (DGF) in kidney transplant patients. Company disclosures state that UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

Unicycive reports that UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. The company notes that mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease, and describes UNI-494 as having a mechanism of action that restores mitochondrial function. Patent information disclosed by the company indicates issued patents in the U.S. and Europe and a range of patent applications worldwide, with a U.S. patent for UNI-494 to treat chronic kidney disease and stated intellectual property protection extending into 2040.

Regulatory and Clinical-Stage Status

Unicycive characterizes itself as a clinical-stage biotechnology company. Its lead program, OLC, has been the subject of an NDA to the FDA for the treatment of hyperphosphatemia in CKD patients on dialysis. Company press releases describe a regulatory history that includes submission of an NDA, receipt of a Complete Response Letter (CRL) from the FDA related to the compliance status of a third-party manufacturing vendor, a Type A meeting with the FDA to discuss resolution of that deficiency, and a subsequent resubmission of the NDA. The company has reported that no additional issues were raised by the FDA regarding preclinical, clinical, or safety data in connection with the CRL, and that European Union regulatory authorities inspected the third-party manufacturing vendor and identified no deficiencies.

For UNI-494, Unicycive has disclosed completion of a Phase 1 dose-ranging safety study in healthy volunteers and the receipt of orphan drug designation for prevention of delayed graft function in kidney transplant patients. The company has also highlighted the issuance of a new U.S. patent for UNI-494 to treat chronic kidney disease, as part of its broader intellectual property portfolio.

Capital Markets and Corporate Actions

Unicycive’s common stock is registered under Section 12(b) of the Securities Exchange Act of 1934 and listed on the Nasdaq Capital Market under the trading symbol UNCY, as confirmed in multiple Form 8-K filings. The company has used at-the-market (ATM) equity offerings under a sales agreement with a sales agent to raise capital, and has disclosed an amendment to increase the aggregate offering capacity under that ATM program.

In a separate corporate action, Unicycive’s board of directors implemented a reverse stock split of its common stock at a ratio of 1-for-10, following stockholder approval. According to the company’s Form 8-K, the reverse stock split became effective in June 2025 and reduced the number of issued and outstanding shares while leaving the number of authorized shares and the par value per share unchanged. The company reported that the reverse split affected all stockholders uniformly, except for immaterial changes resulting from the treatment of fractional shares, and that proportionate adjustments were made to outstanding stock options, warrants, and preferred stock conversion terms.

Legal and Listing Status

Unicycive has disclosed that it is an emerging growth company as defined under applicable SEC rules. In a Form 8-K filed in August 2025, the company reported becoming aware of a purported securities class action lawsuit filed in the United States District Court for the Northern District of California, alleging violations of federal securities laws in connection with public statements relating to its NDA for OLC. Unicycive stated that it believes the claims are meritless and intends to defend the lawsuit.

In another Form 8-K, the company announced that it had regained compliance with the Nasdaq Stock Market continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq Listing Qualifications. The company’s common stock continues to trade on the Nasdaq Capital Market under the symbol UNCY.

Financial Reporting and Cash Position Disclosures

Through its periodic press releases and associated Form 8-K filings, Unicycive provides updates on research and development expenses, general and administrative expenses, other income or expenses, and net income or loss attributable to common stockholders. The company has also disclosed its cash and cash equivalents balances at various quarter-end dates and has described its expected cash runway in qualitative terms. These disclosures are presented as part of its financial results and preliminary financial information and are subject to the usual limitations and review processes described in its filings.

Pipeline Overview

• Oxylanthanum Carbonate (OLC): Investigational oral phosphate binder for hyperphosphatemia in CKD patients on dialysis; NDA submitted via the 505(b)(2) pathway; supported by multiple clinical and preclinical studies and CMC data; protected by a global patent portfolio with composition-of-matter patents and potential term extensions.
• UNI-494: Investigational therapy intended for conditions related to acute kidney injury; described as a nicotinamide ester derivative and selective ATP-sensitive mitochondrial potassium channel activator; has completed a Phase 1 dose-ranging safety study in healthy volunteers; holds FDA orphan drug designation for prevention of delayed graft function in kidney transplant patients; protected by patents and applications in multiple jurisdictions.

Industry Context as Described by the Company

Unicycive’s public materials emphasize the burden of kidney disease and related complications. For hyperphosphatemia in ESRD, the company cites external literature describing the high prevalence of the condition among dialysis patients and its association with increased mortality and hospitalization. For acute kidney injury and delayed graft function, Unicycive references the role of mitochondrial dysfunction in kidney disease progression and the clinical impact of acute kidney injury on morbidity, mortality, and the risk of chronic kidney disease and end stage renal disease.

Summary

According to its own descriptions in press releases and SEC filings, Unicycive Therapeutics, Inc. is a Nasdaq-listed, clinical-stage biotechnology company focused on kidney diseases. Its lead investigational product, oxylanthanum carbonate, targets hyperphosphatemia in CKD patients on dialysis through an oral phosphate binder that uses proprietary nanoparticle technology and is being advanced via the FDA 505(b)(2) pathway. Its second program, UNI-494, is a mitochondrial-targeted therapy intended for conditions related to acute kidney injury and has received orphan drug designation for prevention of delayed graft function in kidney transplant patients. The company supports these programs with clinical trial data, regulatory interactions, and an intellectual property portfolio, and finances its operations in part through equity offerings and other capital markets activities disclosed in its SEC filings.