UNCY Unicycive Therapeutics, Inc.
Legal ·
Unicycive disclosed in an 8-K dated September 28, 2026 that a second securities class action was filed on September 3, 2026 against the company and certain of its officers over its oxylanthanum carbonate application. An earlier class action and two derivative suits are pending in the same federal court.
Unicycive said a securities class action was filed in the Northern District of California against the company and certain of its officers, who are not named. The suit concerns statements about its oxylanthanum carbonate application. The company calls the claims meritless.
Nasdaq confirmed on July 7, 2025 that Unicycive's shares had averaged at least $1.00 after a 1:10 reverse stock split took effect on June 20, 2025. The release does not say what the FDA has done on the company's lead candidate, which had a PDUFA date of June 28, 2025.
Unicycive Therapeutics is a clinical-stage biotechnology company focused on kidney disease. Its business model is to license technologies and drugs and develop them toward approval, first in the U.S., before partnering with global biopharmaceutical companies in the rest of the world. Its two programs are oxylanthanum carbonate, a next-generation phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis, and UNI-494, a drug candidate for acute kidney injury. Oxylanthanum carbonate uses nanoparticle technology and is intended to be swallowed whole, which the company says could reduce pill burden. The company received a Complete Response Letter in June 2025 that cited a third-party manufacturing vendor for deficiencies, resubmitted its NDA in December 2025, and holds a PDUFA target action date of June 29, 2026. UNI-494 is described as a potential first-in-class drug for acute kidney injury. The two licensed programs came from Spectrum Pharmaceuticals and Sphaera Pharma.
| Product or program | What it is | Stage |
|---|---|---|
| Oxylanthanum carbonate (OLC) | Next-generation phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis | NDA resubmitted to the FDA; PDUFA target action date June 29, 2026 |
| UNI-494 | Novel drug candidate for the treatment of acute kidney injury | Phase I study in healthy volunteers completed in 2024 |
| Line | FY2025 | FY2024 |
|---|---|---|
| Research and development | $9.1 million | $20.0 million |
| Net income (loss) | -$26.6 million | -$36.7 million |
| Cash from operations | -$31.3 million | -$28.6 million |
| Cash and equivalents | $29.2 million | $26.1 million |
| Short-term investments | $12.1 million |
Our latest story on this, dated Jul 8, 2025: "Unicycive regains Nasdaq minimum bid price compliance after reverse split". The story links the filing or release it is based on. Read the story.
Our latest story on this, dated Sep 28, 2026: "Unicycive discloses another securities class action over its OLC application". The story links the filing or release it is based on. Read the story.
Unicycive Therapeutics, Inc. trades under the ticker UNCY on NASDAQ.
Unicycive Therapeutics, Inc. is listed on NASDAQ.
The SEC Central Index Key (CIK) for Unicycive Therapeutics, Inc. is 1766140. Its filings are on SEC EDGAR.
27,855,257 shares as of 2026-08-12, per the cover page of its 10-Q filed 2026-08-12.
Our directory records Unicycive Therapeutics, Inc. under United States.
Our directory classifies Unicycive Therapeutics, Inc. as: Biotechnology. This is a directory classification, not a description of the pipeline.
The ISIN recorded for Unicycive Therapeutics, Inc. is US90466Y2028.
aibio.space lists Unicycive Therapeutics, Inc. among 2,820 public biotech companies and publishes its news here as stories appear.
SEC records list its state or country of incorporation as DE.
Unicycive Therapeutics is a clinical-stage biotechnology company focused on kidney disease. Its business model is to license technologies and drugs and develop them toward approval, first in the U.S., before partnering with global biopharmaceutical companies in the rest of the world.
Oxylanthanum carbonate (OLC): Next-generation phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis Stage: NDA resubmitted to the FDA; PDUFA target action date June 29, 2026.
UNI-494: Novel drug candidate for the treatment of acute kidney injury Stage: Phase I study in healthy volunteers completed in 2024.
Unicycive Therapeutics, Inc. reported a net loss of $26.6 million for the fiscal year ended Dec 31, 2025, and used $31.3 million of cash in operations, per its annual report to the SEC.
Disclosed a shareholder lawsuit, subpoena or other legal matter. SEC Form 8-K (Items 8.01). Source
Reported a financing. SEC Form 8-K (Items 1.01,9.01). Source
Disclosed a shareholder lawsuit, subpoena or other legal matter. SEC Form 10-K. Source
Reported a financing. SEC Form 424B5. Source
Disclosed a shareholder lawsuit, subpoena or other legal matter. SEC Form 8-K (Items 8.01). Source
Reported a notice from its stock exchange about continued listing requirements. SEC Form 8-K (Items 8.01,9.01). Source
Reported a reverse stock split. SEC Form 8-K (Items 3.03,5.03,8.01,9.01). Source
Filed a final prospectus for a securities offering. SEC Form 424B5. Source
Reported a shareholder vote on a reverse stock split or more authorized shares. SEC Form 8-K (Items 5.07,9.01). Source
Reported substantial doubt about its ability to continue as a going concern. SEC Form 10-Q. Source
Asked shareholders to approve a reverse stock split. SEC Form DEF 14A. Source
Asked shareholders to approve a reverse stock split. SEC Form PRE 14A. Source
Reported a notice from its stock exchange about continued listing requirements. SEC Form 8-K (Items 8.01). Source
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