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 develops investigational treatments for kidney diseases, with news centered on its clinical-stage pipeline, regulatory communications, financial results, and investor presentations. Its lead program, oxylanthanum carbonate, is an oral phosphate binder being developed for hyperphosphatemia in chronic kidney disease patients on dialysis, and company updates frequently address NDA activity, chemistry, manufacturing and controls matters, and commercial-readiness planning.
Unicycive also reports developments for UNI-494, a drug candidate for conditions related to acute kidney injury, including its FDA orphan drug designation for prevention of delayed graft function in kidney transplant patients and completed Phase 1 safety work. Recurring announcements include business updates, conference participation, and capital or cash-position disclosures tied to advancing the kidney-disease portfolio.
Unicycive Therapeutics (Nasdaq: UNCY) reported first quarter 2026 results and a business update. The FDA review of oxylanthanum carbonate (OLC) NDA resubmission remains on track with a PDUFA target action date of June 29, 2026.
Unaudited cash and investments were $57.1 million, which the company believes will fund operations into 2027. Q1 2026 R&D expense was $1.6 million, G&A expense was $6.8 million, and net loss attributable to common stockholders (basic) was $(12.8) million, or $(0.54) per share.
Unicycive Therapeutics (Nasdaq: UNCY) announced that CEO Shalabh Gupta, M.D., will present at the 25th Annual Needham Virtual Healthcare Conference on April 15, 2026 at 3:45 p.m. ET. A live and archived webcast will be available via the company Investor Events and Presentations page.
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.
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.