Welcome to our dedicated page for Unicycive Therapeutics news (Ticker: UNCY), a resource for investors and traders seeking the latest updates and insights on Unicycive Therapeutics stock.
Unicycive Therapeutics, Inc. (UNCY) is a clinical-stage biotechnology company whose news flow centers on the development and regulatory progress of kidney disease therapies. Company press releases highlight advances for its lead investigational product oxylanthanum carbonate (OLC), an oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis, and for its second program UNI-494, which is intended for conditions related to acute kidney injury.
Investors following UNCY news can expect detailed updates on regulatory interactions with the U.S. Food and Drug Administration, including New Drug Application submissions, Complete Response Letters, Type A meetings, and NDA resubmissions for OLC. The company also reports on pivotal and Phase 2 clinical trial results, analyses of pill burden and phosphate control, and publications of OLC data in peer-reviewed journals such as the Clinical Journal of the American Society of Nephrology.
Unicycive’s news releases frequently cover financial results, cash runway commentary, and capital markets activities, such as at-the-market equity offerings and reverse stock split implementation, as disclosed in associated Form 8-K filings. Additional news items include participation in healthcare and investor conferences, issuance of new patents for UNI-494 and its use in chronic kidney disease, and corporate updates on Nasdaq listing compliance and legal matters, including disclosure of a purported securities class action.
This UNCY news page aggregates these company-issued updates so readers can review clinical data milestones, regulatory developments, intellectual property announcements, and financial disclosures in one place. For those tracking the progress of oxylanthanum carbonate and UNI-494, the news feed provides a chronological view of Unicycive’s communications about its kidney disease pipeline and corporate activities.
Unicycive Therapeutics (Nasdaq: UNCY) announced that CEO Shalabh Gupta, M.D. will take part in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on Wednesday, February 11, 2026 at 1:30 p.m. ET.
According to the company, a live webcast and archived replay will be available via the Unicycive investor website under Events and Presentations. Investors seeking 1x1 meetings should contact their Guggenheim conference representative.
Unicycive Therapeutics (NASDAQ: UNCY) announced FDA acceptance of the resubmitted NDA for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in dialysis patients, designated a Class II complete response with a PDUFA target date of June 27, 2026. The NDA is supported by three clinical studies, multiple preclinical studies and CMC data. The FDA raised no concerns about OLC's preclinical, clinical, or safety data. The company ended 2025 with $41.3M in cash, cash equivalents and short-term investments, providing a stated cash runway into 2027 and supporting commercial launch preparation.
Unicycive Therapeutics (NASDAQ: UNCY) resubmitted its 505(b)(2) New Drug Application for oxylanthanum carbonate (OLC) for treatment of hyperphosphatemia in dialysis patients.
The company expects a new PDUFA date in 1H 2026 and notes NDA resubmission acceptance is typically acknowledged within 30 days, with review completion target of 6 months. Resubmission follows progress by the original third‑party manufacturing vendor toward FDA compliance, a Type A FDA meeting in September 2025 where no additional issues were raised, and an EU inspection that identified no deficiencies. Management states a cash runway into 2027.
Unicycive Therapeutics (Nasdaq: UNCY) announced that CEO Shalabh Gupta, M.D. will participate in two investor events in December 2025: a Piper Sandler 37th Annual Healthcare Conference fireside chat on Dec 3, 2025 at 10:00 a.m. ET and a Noble Capital Markets virtual presentation on Dec 10, 2025 at 10:00 a.m. PT. Live and archived webcasts will be available on the company's Investor Events and Presentations webpage. Investors seeking a 1x1 meeting should contact their Piper Sandler conference representative to schedule.
Unicycive Therapeutics (Nasdaq: UNCY) reported Q3 2025 results and provided a business update on oxylanthanum carbonate (OLC).
Key points: management plans to resubmit the NDA for OLC by year-end with a potential PDUFA in H1 2026 after a Type A meeting with the FDA that identified a single manufacturing-related deficiency in the CRL. A third-party vendor inspection in the EU found no deficiencies. New open-label pivotal data presented at ASN Kidney Week 2025 showed OLC reduced pill volume by 7x and pill count by 2x versus prior phosphate binders. Financials: cash $42.7M with runway into 2027; Q3 R&D $3.0M, G&A $4.4M, and net loss $6.0M.
Unicycive Therapeutics (NASDAQ: UNCY) announced that CEO Shalabh Gupta, M.D. will speak in a fireside chat at the Guggenheim 2nd Annual Healthcare Innovation Conference on Monday, November 10, 2025 at 3:30 p.m. ET.
A live webcast and archived replay will be available on the company's Investor website under Events and Presentations. Investors seeking a 1x1 meeting with management should contact their conference representative to schedule.
Unicycive Therapeutics (Nasdaq: UNCY) will present new clinical data for oxylanthanum carbonate (OLC) at ASN Kidney Week 2025 on Nov 6, 2025. An open-label, single-arm pivotal trial enrolled 86 dialysis patients (72 completed) comparing pretrial binders to OLC. Key results: mean daily pill volume fell from 9.3 cm3 to 1.4 cm3 (~7x reduction), mean pills/day fell from 8.3 to 3.9, and patients with serum phosphate ≤5.5 mg/dL rose from 59% to 91% after OLC titration. The company said it plans to resubmit its New Drug Application by year-end. Poster available on the company website after the Nov 6 presentation.
Unicycive Therapeutics (Nasdaq: UNCY) reported outcomes from an FDA Type A meeting and said it plans to resubmit the NDA for Oxylanthanum Carbonate (OLC) by year-end 2025 after receiving a Complete Response Letter (CRL) on June 30, 2025.
The CRL cited a single deficiency tied to the compliance status of a third-party manufacturing vendor; no preclinical, clinical, or safety concerns were identified. The company said FDA meeting minutes were constructive and it is engaging the vendor to resolve the issue, potentially yielding a PDUFA date in H1 2026.
Unicycive reported $42 million cash as of September 30, 2025, which it says provides a cash runway into 2027 to support the resubmission, potential approval, and commercialization preparations for OLC.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease treatments, has announced its participation in two upcoming investor events in September 2025.
CEO Shalabh Gupta will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 10 at 8:30 a.m. ET, followed by another fireside chat at the Truist Securities Virtual event on September 17 at 10 a.m. ET. Webcasts will be available on the company's investor relations website.
Unicycive Therapeutics (Nasdaq: UNCY) has secured a new U.S. Patent (12,377,082) for UNI-494, extending intellectual property protection until 2040 for treating Chronic Kidney Disease (CKD). This patent complements an existing patent for UNI-494's use in treating Acute Kidney Injury.
The company has already completed a Phase I clinical study of UNI-494 in healthy volunteers and received Orphan Drug Designation for preventing delayed graft function in kidney transplant patients. While Unicycive's primary focus remains on FDA approval for oxylanthanum carbonate, this patent strengthens their intellectual property portfolio and enhances partnership opportunities.
FAQ
What is the current stock price of Unicycive Therapeutics (UNCY)?
What is the market cap of Unicycive Therapeutics (UNCY)?
