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 (UNCY) appointed Meredith Manning to its Board of Directors as it prepares for a potential transition to commercial operations.
Manning will serve on the Audit, Compensation, and Nominating and Corporate Governance Committees, chairing the latter. She has more than 25 years of global biopharmaceutical experience and most recently served as Soleno Therapeutics’ Chief Commercial Officer, where she led the U.S. launch of VYKAT XR. Unicycive recently resubmitted its new drug application for oxylanthanum carbonate, its investigational kidney-disease treatment. The company expects Manning’s commercialization experience to support preparations for potential approval.
Unicycive Therapeutics (UNCY) resubmitted its FDA new drug application for oxylanthanum carbonate to treat high phosphate levels in dialysis patients.
The application includes manufacturing data from a new drug-product vendor, 12 months of product stability data and laboratory comparisons between the two vendors. The new vendor’s facility received a “No Action Indicated” FDA inspection classification in March 2024. Unicycive expects the FDA to accept the application within 30 days and assign a review deadline six months after resubmission.
The FDA’s June 2026 response letter cited previously identified manufacturing deficiencies at the original vendor. The FDA raised no concerns about clinical efficacy or safety data and requested no additional company data. The original vendor’s reinspection had not occurred as of September 29, 2026. Unaudited cash, cash equivalents and marketable securities totaled $61.4 million at June 30, supporting an expected cash runway into the second half of 2027.
Unicycive Therapeutics (Nasdaq: UNCY) announced that CEO Shalabh Gupta, M.D., will present at the H.C. Wainwright 28th Annual Global Investment Conference on Tuesday, September 15, 2026, at 11 a.m. ET. A live and archived webcast will be available via the Investors section of the Unicycive website.
Unicycive Therapeutics (Nasdaq: UNCY) reported second quarter 2026 results and a business update focused on oxylanthanum carbonate (OLC) for hyperphosphatemia in dialysis patients. In June 2026, the company received an FDA Complete Response Letter (CRL) again citing third-party manufacturing deficiencies, with no new clinical efficacy or safety concerns and no additional data requested.
The third-party vendor has received written FDA notification that a facility inspection has been assigned, and Unicycive expects to resubmit the OLC NDA following a successful inspection. As of June 30, 2026, unaudited cash, cash equivalents and marketable securities totaled $61.4 million, which the company expects will fund operations into 2027.
For Q2 2026, R&D expense was $2.8 million and G&A was $7.4 million. Net loss attributable to common stockholders narrowed to $1.7 million, or $(0.06) per share, from $6.5 million, or $(0.52), mainly due to a change in warrant liability fair value.
Unicycive Therapeutics (Nasdaq: UNCY) received an FDA Complete Response Letter (CRL) for its resubmitted oxylanthanum carbonate (OLC) NDA for treating hyperphosphatemia in CKD patients on dialysis.
The CRL cites previously identified third-party manufacturing deficiencies; FDA raised no efficacy or safety concerns and requested no new data. Label and packaging discussions are ongoing.
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.