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Unicycive Therapeutics Inc SEC Filings

UNCY NASDAQ

Welcome to our dedicated page for Unicycive Therapeutics SEC filings (Ticker: UNCY), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.

Parsing a 200-page biotech filing packed with clinical trial minutiae and cash-runway calculations is tough—especially when Unicycive Therapeutics� renal drug pipeline means every 10-K hides critical FDA milestones. If you have ever wondered, “How do I follow Unicycive Therapeutics insider trading Form 4 transactions or locate their latest quarterly earnings report 10-Q filing?�, you are not alone.

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Rhea-AI Summary

Unicycive Therapeutics, Inc. (Nasdaq: UNCY) filed a Form 8-K dated 30 June 2025 to disclose a material regulatory development and preliminary liquidity data.

The company announced that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for its New Drug Application covering oxylanthanum carbonate (OLC), proposed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. The CRL indicates that the agency will not approve the NDA in its current form; specific deficiencies were not disclosed in the filing. The news was disseminated through a press release furnished as Exhibit 99.1 and incorporated into Items 2.02 and 8.01 of this report.

Management also provided a preliminary, unaudited cash figure of approximately $20.7 million as of 30 June 2025. The company has not yet completed its condensed consolidated financial statements for the quarter ended 30 June 2025, and its independent registered public accounting firm has performed no review procedures on this estimate. Accordingly, the figure may change when full second-quarter results are finalized.

The filing contains no additional earnings data, major transactions, or financing events. Exhibits include the referenced press release (Ex. 99.1) and the Inline XBRL cover page file (Ex. 104). Investors should monitor future disclosures for the FDA’s requested actions and for finalized Q2 results.

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Rhea-AI Summary

Unicycive Therapeutics (NASDAQ: UNCY) has announced a 1-for-10 reverse stock split effective June 18, 2025, at 4:01 PM ET. The company's common stock began trading on a split-adjusted basis on the Nasdaq Capital Market on June 20, 2025, maintaining its "UNCY" symbol but with a new CUSIP number.

Key details of the reverse split:

  • Reduced outstanding shares from 126,409,281 to approximately 12,768,239
  • No fractional shares issued - fractional interests rounded up to the next whole share
  • Proportionate adjustments made to stock options, warrants, and Series A-2 prime preferred stock conversion prices
  • No change to authorized shares or par value
  • No material change to stockholders' percentage ownership or voting power

The reverse split follows stockholder approval on June 9, 2025, which authorized the board to implement a split ratio between 1-for-2 and 1-for-20 before June 9, 2026. This corporate action affects multiple registration statements on Forms S-3 and S-8 currently on file with the SEC.

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FAQ

What is the current stock price of Unicycive Therapeutics (UNCY)?

The current stock price of Unicycive Therapeutics (UNCY) is $4.77 as of June 30, 2025.

What is the market cap of Unicycive Therapeutics (UNCY)?

The market cap of Unicycive Therapeutics (UNCY) is approximately 85.8M.

What is the primary focus of Unicycive Therapeutics?

Unicycive Therapeutics focuses on developing innovative treatments for kidney diseases, addressing both hyperphosphatemia and acute kidney injury through its novel drug candidates.

What are the main products in Unicycive's pipeline?

The company is developing Renazorb, a novel phosphate-binding agent for hyperphosphatemia, and UNI-494, a new chemical entity for the treatment of acute kidney injury, with both undergoing rigorous clinical evaluation.

How does Unicycive Therapeutics differentiate itself in the biotechnology sector?

The company differentiates itself by concentrating on high unmet needs in kidney diseases, leveraging strong intellectual property protection and advanced clinical research to support its unique therapeutic candidates.

What steps does the company take to ensure clinical safety and efficacy?

Unicycive employs a thorough research and development process that includes extensive preclinical studies and carefully designed clinical trials to validate the safety and efficacy of its drug candidates.

How important is intellectual property to Unicycive Therapeutics?

Intellectual property is a cornerstone of the company’s strategy as it safeguards its innovations, ensuring market exclusivity and long-term value for its novel therapeutic agents.

What is the significance of Renazorb in the treatment landscape?

Renazorb represents a novel approach to managing hyperphosphatemia in kidney disease patients by effectively binding phosphate, a critical step in preventing complications associated with chronic renal disorders.

How does Unicycive contribute to the field of renal therapeutics?

Through its focused research on both chronic and acute kidney conditions, Unicycive advances clinical knowledge and offers innovative therapeutic options, thereby addressing significant healthcare challenges in renal medicine.

Who are the key stakeholders that benefit from Unicycive's research?

Patients, healthcare professionals, and clinical researchers benefit from the company’s commitment to developing safe and effective treatments for kidney disease, thereby enhancing patient care and advancing clinical science.
Unicycive Therapeutics Inc

NASDAQ:UNCY

UNCY Rankings

UNCY Stock Data

85.77M
11.43M
6.12%
60.39%
1.35%
Biotechnology
Pharmaceutical Preparations
United States
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