Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update
Rhea-AI Summary
Unicycive Therapeutics (Nasdaq: UNCY) reported full-year 2025 results and a business update on March 30, 2026. The company said the FDA accepted its NDA resubmission for oxylanthanum carbonate (OLC) with a PDUFA target action date of June 29, 2026, and commercial readiness is underway for a potential 3Q26 launch.
Financials: 2025 R&D $9.1M, G&A $20.4M, other income $3.0M, net loss $26.6M ($1.67/share). Unaudited cash, cash equivalents and marketable securities were $54.9M as of March 30, 2026, with runway into 2027.
Positive
- FDA acceptance of OLC NDA resubmission with PDUFA date June 29, 2026
- Cash runway of $54.9M supports operations into 2027
- Net loss improved to $26.6M from $37.8M year-over-year
- R&D expense down to $9.1M from $20.0M (reduced drug development costs)
Negative
- G&A increase to $20.4M from $12.1M due to commercial launch preparation
- Reliance on approval: commercial launch timing and revenue depend on FDA decision by June 29, 2026
News Market Reaction – UNCY
In the Mar 30 session, UNCY declined 4.38%, reflecting a moderate negative market reaction. Argus tracked a peak move of +9.0% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 12 | Q3 2025 earnings | Positive | +7.3% | Q3 results plus OLC resubmission plans and supportive clinical data. |
| Aug 14 | Q2 2025 earnings | Positive | +5.0% | Q2 update highlighting strong OLC efficacy data and lower R&D spend. |
| May 14 | Q1 2025 earnings | Positive | -7.8% | Q1 results with earlier PDUFA date and net income from warrant effects. |
| Mar 31 | FY 2024 results | Negative | -6.4% | Full-year 2024 showing higher net loss and increased R&D and G&A. |
| Nov 13 | Q3 2024 earnings | Positive | -1.3% | Q3 2024 update with OLC NDA acceptance and UNI-494 trial progress. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings and business updates have produced mixed reactions, with both sharp gains and notable selloffs around OLC regulatory milestones and cash runway commentary.
Across prior earnings and business updates, Unicycive repeatedly tied its financial story to oxylanthanum carbonate (OLC) milestones and cash runway visibility. Events on Mar 31, 2025 and later emphasized PDUFA timelines, shifts in R&D and G&A spending, and evolving cash positions from $19.8M to $42.7M. Price reactions ranged from about -7.83% to +7.31%, showing no consistent directional pattern. Today’s full-year 2025 results and NDA review status continue that theme of balancing regulatory progress with operating losses and launch preparation costs.
Key Terms
new drug application (nda) regulatory
u.s. food and drug administration (fda) regulatory
prescription drug user fee act (pdufa) regulatory
hyperphosphatemia medical
chronic kidney disease medical
bioequivalence medical
chemistry, manufacturing and controls (cmc) regulatory
tolerability study medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026
- Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26
- As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled
$54.9 million , with expected runway into 2027
LOS ALTOS, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2025, and provided a business update.
“This year is shaping up to be pivotal for Unicycive, underscored by the U.S. Food and Drug Administration’s acceptance of our New Drug Application resubmission for OLC and the potential for approval and launch later this year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With hyperphosphatemia still uncontrolled in nearly
Key Highlights & Upcoming Milestones
- In January 2026, the Company announced the FDA has accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study in patients with CKD on dialysis), multiple preclinical studies and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical or safety data for OLC included in the original NDA submission. The resubmission in December 2025 was based on the progress made by the third-party manufacturing vendor responsible for the drug product (Drug Product).
- As part of Unicycive’s continued preparation to support a potential launch of OLC later this year, the Company is continuing to strengthen its commercial infrastructure and advance market readiness initiatives.
Financial Results for the Year Ended December 31, 2025
Research and Development (R&D) expenses were
General and Administrative (G&A) expenses were
Other income was
Net loss attributable to common stockholders for the year ended December 31, 2025 was
As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Media Contact:
Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com
SOURCE: Unicycive Therapeutics, Inc.
| Unicycive Therapeutics, Inc. | ||||||||
| Balance Sheets | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2024 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 26,142 | $ | 29,198 | ||||
| Prepaid expenses and other current assets | 4,806 | 7,692 | ||||||
| Marketable securities | - | 12,071 | ||||||
| Total current assets | 30,948 | 48,961 | ||||||
| Right of use asset, net | 645 | 108 | ||||||
| Property and equipment, net | 75 | 66 | ||||||
| Total assets | $ | 31,668 | $ | 49,135 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,058 | $ | 383 | ||||
| Accrued liabilities | 3,562 | 1,523 | ||||||
| Warrant liability | 18,936 | 16,915 | ||||||
| Operating lease liability - current | 564 | 117 | ||||||
| Total current liabilities | 24,120 | 18,938 | ||||||
| Operating lease liability - long term | 117 | - | ||||||
| Total liabilities | 24,237 | 18,938 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Series A-2 Prime preferred stock, | - | - | ||||||
| Series B-2 preferred stock, | - | - | ||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 11 | 22 | ||||||
| Accumulated other comprehensive loss | - | (1 | ) | |||||
| Additional paid-in capital | 108,690 | 158,001 | ||||||
| Accumulated deficit | (101,270 | ) | (127,825 | ) | ||||
| Total stockholders’ equity | 7,431 | 30,197 | ||||||
| Total liabilities and stockholders’ equity | $ | 31,668 | $ | 49,135 | ||||
| Unicycive Therapeutics, Inc. | ||||||||
| Statements of Operations | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| Year Ended | Year Ended | |||||||
| December 31, | December 31, | |||||||
| 2024 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 20,014 | $ | 9,121 | ||||
| General and administrative | 12,103 | 20,396 | ||||||
| Total operating expenses | 32,117 | 29,517 | ||||||
| Loss from operations | (32,117 | ) | (29,517 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 1,261 | 1,012 | ||||||
| Interest expense | (71 | ) | (71 | ) | ||||
| Change in fair value of warrant liability | (5,802 | ) | 2,021 | |||||
| Total other income (expenses) | (4,612 | ) | 2,962 | |||||
| Net loss | (36,729 | ) | (26,555 | ) | ||||
| Other comprehensive loss: | ||||||||
| Unrealized loss on marketable securities, net | - | (1 | ) | |||||
| Net comprehensive loss | $ | (36,729 | ) | $ | (26,556 | ) | ||
| Dividend to Series B-1 preferred stockholders | (1,095 | ) | - | |||||
| Net loss attributable to common stockholders | $ | (37,824 | ) | $ | (26,555 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (5.65 | ) | $ | (1.67 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 6,698,513 | 15,886,876 | ||||||
